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1.
PLoS One ; 17(11): e0277790, 2022.
Article in English | MEDLINE | ID: covidwho-2119391

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection may cause severe life-threatening diseases called acute respiratory distress syndrome (ARDS) owing to cytokine storms. The mortality rate of COVID-19-related ARDS is as high as 40% to 50%. However, effective treatment for the extensive release of acute inflammatory mediators induced by hyperactive and inappropriate immune responses is very limited. Many anti-inflammatory drugs with variable efficacies have been investigated. Colchicine inhibits interleukin 1 beta (IL-1ß) and its subsequent inflammatory cascade by primarily blocking pyrin and nucleotide-binding domain leucine-rich repeat and pyrin domain containing receptor 3 (NLRP3) activation. Therefore, this cheap, widely available, oral drug might provide an added benefit in combating the cytokine storm in COVID-19. Here, we sought to determine whether adding colchicine to other standards of care could be beneficial for moderate COVID-19 pneumonia in terms of the requirement for advanced respiratory support and mortality. METHODS AND FINDINGS: This blinded placebo-controlled drug trial was conducted at the Dhaka Medical College Hospital, Dhaka, Bangladesh. A total of 300 patients with moderate COVID-19 based on a positive RT-PCR result were enrolled based on strict selection criteria from June 2020 to November 2020. Patients were randomly assigned to either treatment group in a 1:1 ratio. Patients were administered 1.2 mg of colchicine on day 1 followed by daily treatment with 0.6 mg of colchicine for 13 days or placebo along with the standard of care. The primary outcome was the time to clinical deterioration from randomization to two or more points on a seven-category ordinal scale within the 14 days post-randomization. Clinical outcomes were also recorded on day 28. The primary endpoint was met by 9 (6.2%) patients in the placebo group and 4 (2.7%) patients in the colchicine group (P = 0.171), which corresponds to a hazard ratio (95% CI) of 0.44 (0.13-1.43). Additional analysis of the outcomes on day 28 revealed significantly lower clinical deterioration (defined as a decrease by two or more points) in the colchicine group, with a hazard ratio [95%CI] of 0.29 [0.098-0.917], (P = 0.035). Despite a 56% reduction in the need for mechanical ventilation and death with colchicine treatment on day 14, the reduction was not statistically significant. On day 28, colchicine significantly reduced clinical deterioration measured as the need for mechanical ventilation and all-cause mortality. CONCLUSION: Colchicine was not found to have a significant beneficial effect on reducing mortality and the need for mechanical ventilation. However, a delayed beneficial effect was observed. Therefore, further studies should be conducted to evaluate the late benefits of colchicine. CLINICAL TRIAL REGISTRATION: Clinical trial registration no: ClinicalTrials.gov Identifier: NCT04527562 https://www.google.com/search?client=firefox-b-d&q=NCT04527562.


Subject(s)
COVID-19 , Clinical Deterioration , Respiratory Distress Syndrome , Humans , COVID-19/drug therapy , SARS-CoV-2 , Colchicine/therapeutic use , Bangladesh , Cytokine Release Syndrome , Treatment Outcome , Respiratory Distress Syndrome/drug therapy
2.
J Physiol Pharmacol ; 73(3)2022 Jun.
Article in English | MEDLINE | ID: covidwho-2091455

ABSTRACT

Systemic inflammation is a hallmark of severe coronavirus disease-19 (COVID-19). Anti-inflammatory therapy is considered crucial to modulate the hyperinflammatory response (cytokine storm) in hospitalized COVID-19 patients. There is currently no specific, conclusively proven, cost-efficient, and worldwide available anti-inflammatory therapy available to treat COVID-19 patients with cytokine storm. The present study aimed to investigate the treatment benefit of oral colchicine for hospitalized COVID-19 patients with suspected cytokine storm. Colchicine is an approved drug and possesses multiple anti-inflammatory mechanisms. This was a pilot, open-label randomized controlled clinical trial comparing standard of care (SOC) plus oral colchicine (colchicine arm) vs. SOC alone (control arm) in non-ICU hospitalized COVID-19 patients with suspected cytokine storm. Colchicine treatment was initiated within first 48 hours of admission delivered at 1.5 mg loading dose, followed by 0.5 mg b.i.d. for next 6 days and 0.5 mg q.d. for the second week. A total of 96 patients were randomly allocated to the colchicine (n=48) and control groups (n=48). Both colchicine and control group patients experienced similar clinical outcomes by day 14 of hospitalization. Treatment outcome by day 14 in colchicine vs control arm: recovered and discharged alive: 36 (75.0%) vs. 37 (77.1%), remain admitted after 14-days: 4 (8.3%) vs. 5 (10.4%), ICU transferred: 4 (8.3%) vs. 3 (6.3%), and mortality: 4 (8.3%) vs. 3 (6.3%). The speed of improvement of COVID-19 acute symptoms including shortness of breath, fever, cough, the need of supplementary oxygen, and oxygen saturation level, was almost identical in the two groups. Length of hospitalization was on average 1.5 day shorter in the colchicine group. There was no evidence for a difference between the two groups in the follow-up serum levels of inflammatory biomarkers including C-reactive protein (CRP), D-dimer, lactate dehydrogenase (LDH), ferritin, interleukin-6 (IL-6), high-sensitivity troponin T (hs-TnT) and N-terminal pro b-type natriuretic peptide (NT pro-BNP). According to the results of our study, oral colchicine does not appear to show clinical benefits in non-ICU hospitalized COVID-19 patients with suspected cytokine storm. It is possible that the anti-inflammatory pathways of colchicine are not crucially involved in the pathogenesis of COVID-19.


Subject(s)
COVID-19 , Humans , COVID-19/drug therapy , SARS-CoV-2 , Cytokine Release Syndrome/drug therapy , Colchicine/therapeutic use , Hospitalization , Anti-Inflammatory Agents/therapeutic use , Treatment Outcome
3.
J Korean Med Sci ; 37(41): e299, 2022 Oct 24.
Article in English | MEDLINE | ID: covidwho-2089756

ABSTRACT

Multisystem inflammatory syndrome in children and adults (MIS-C/A) was rarely reported as a complication of coronavirus disease 2019 (COVID-19) and potential adverse events following COVID-19 vaccination. Recently, the case definition of MIS-C/A was developed by the Brighton Collaboration Network. However, only a limited number of adult patients with MIS-A following immunization have been reported, and there is still little evidence for adequate treatment. A 57-year-old man presented with fever, headache, vomiting, and hypotension 24 days after receiving the second COVID-19 vaccination with the Pfizer-BioNTech vaccine. According to the Brighton Collaboration Case Definition, the patient met a definitive case of MIS-A after vaccination (level 1 of diagnostic certainty). After administration of medium-dose prednisolone (20 mg/d) with colchicine (1.2 mg/d), all symptoms and signs improved rapidly. The dose of prednisolone was gradually tapered from the third week, and the patient confirmed a full recovery without medication after 8 weeks. This is the first report showing that low-dose steroids in combination with colchicine may be an effective treatment option for MIS-A after vaccination.


Subject(s)
COVID-19 , Humans , Male , Middle Aged , Colchicine/therapeutic use , COVID-19/drug therapy , COVID-19 Vaccines/adverse effects , Prednisolone/therapeutic use , RNA, Messenger , Steroids , Systemic Inflammatory Response Syndrome/diagnosis , Systemic Inflammatory Response Syndrome/drug therapy , Systemic Inflammatory Response Syndrome/etiology , Vaccination/adverse effects
4.
Medicine (Baltimore) ; 101(41): e30998, 2022 Oct 14.
Article in English | MEDLINE | ID: covidwho-2077958

ABSTRACT

BACKGROUND: To date, there has been little agreement on what drug is the "best" drug for treating severe COVID-19 patients. This study aimed to assess the efficacy and safety of different medications available at present for severe COVID-19. METHODS: We searched databases for randomized controlled trials (RCTs) published up to February 28, 2022, with no language restrictions, of medications recommended for patients (aged 16 years or older) with severe COVID-19 infection. We extracted data on trials and patient characteristics, and the following primary outcomes: all-cause mortality (ACM), and treatment-emergent adverse events (TEAEs). RESULTS: We identified 4021 abstracts and of these included 48 RCTs comprising 9147 participants through database searches and other sources. For decrease in ACM, we found that ivermectin/doxycycline, C-IVIG (i.e., a hyperimmune anti-COVID-19 intravenous immunoglobulin), methylprednisolone, interferon-beta/standard-of-care (SOC), interferon-beta-1b, convalescent plasma, remdesivir, lopinavir/ritonavir, immunoglobulin gamma, high dosage sarilumab (HS), auxora, and imatinib were effective when compared with placebo or SOC group. We found that colchicine and interferon-beta/SOC were only associated with the TEAEs of severe COVID-19 patients. CONCLUSION: This study suggested that ivermectin/doxycycline, C-IVIG, methylprednisolone, interferon-beta/SOC, interferon-beta-1b, convalescent plasma (CP), remdesivir, lopinavir/ritonavir, immunoglobulin gamma, HS, auxora, and imatinib were efficacious for treating severe COVID-19 patients. We found that most medications were safe in treating severe COVID-19. More large-scale RCTs are still needed to confirm the results of this study.


Subject(s)
COVID-19 , Coronavirus Infections , Pneumonia, Viral , COVID-19/drug therapy , COVID-19/therapy , Colchicine/therapeutic use , Coronavirus Infections/therapy , Doxycycline/therapeutic use , Humans , Imatinib Mesylate/therapeutic use , Immunization, Passive , Immunoglobulins, Intravenous/therapeutic use , Interferon beta-1b/therapeutic use , Ivermectin/adverse effects , Lopinavir/therapeutic use , Methylprednisolone/therapeutic use , Network Meta-Analysis , Pandemics , Pneumonia, Viral/therapy , Randomized Controlled Trials as Topic , Ritonavir/therapeutic use
5.
Medicine (Baltimore) ; 101(39): e30618, 2022 Sep 30.
Article in English | MEDLINE | ID: covidwho-2051706

ABSTRACT

INTRODUCTION: Colchicine acts upstream in the cytokines cascade by inhibiting the nod-like receptor protein 3 (NLRP3) inflammasome while interleukin 6 (IL-6) receptor antagonists, such as tocilizumab, block the end result of the cytokines cascade. Hence, adding colchicine to tocilizumab with the aim of blocking the early and end products of the cytokines cascade, might reduce the risk of developing cytokine storm. METHODS AND ANALYSIS: We aim to conduct an open-label randomized controlled trial to evaluate the efficacy and safety of adding colchicine to tocilizumab among patients with severe COVID-19 pneumonia to reduce the rate of invasive mechanical ventilation and mortality. We will include patients with severe COVID-19 pneumonia who received tocilizumab according to our local guidelines. Enrolled patients will be then randomized in 1:1 to colchicine versus no colchicine. Patients will be followed up for 30 days. The primary outcome is the rate of invasive mechanical ventilation and will be determined using Cox proportional hazard model. DISCUSSION: Given colchicine's ease of use, low cost, good safety profile, and having different anti-inflammatory mechanism of action than other IL-6 blockade, colchicine might serve as a potential anti-inflammatory agent among patients with severe COVID-19 pneumonia. This study will provide valuable insights on the use of colchicine in severe COVID-19 when added to IL-6 antagonists. ETHICS AND DISSEMINATION: The Medical Research Center and Institutional Review Board at Hamad Medical Corporation in Qatar approved the study protocol (MRC-01-21-299). Results of the analysis will be submitted for publication in a peer-reviewed journal.


Subject(s)
COVID-19 , Anti-Inflammatory Agents , Antibodies, Monoclonal, Humanized , COVID-19/drug therapy , Colchicine/therapeutic use , Humans , Inflammasomes , Interleukin-6 , NLR Family, Pyrin Domain-Containing 3 Protein , Respiration, Artificial , SARS-CoV-2 , Treatment Outcome
6.
Br J Gen Pract ; 72(720): e446-e455, 2022 07.
Article in English | MEDLINE | ID: covidwho-1924323

ABSTRACT

BACKGROUND: Colchicine has been proposed as a COVID-19 treatment. AIM: To determine whether colchicine reduces time to recovery and COVID-19-related admissions to hospital and/or deaths among people in the community. DESIGN AND SETTING: Prospective, multicentre, open-label, multi-arm, randomised, controlled, adaptive platform trial (PRINCIPLE). METHOD: Adults aged ≥65 years or ≥18 years with comorbidities or shortness of breath, and unwell for ≤14 days with suspected COVID-19 in the community, were randomised to usual care, usual care plus colchicine (500 µg daily for 14 days), or usual care plus other interventions. The co-primary endpoints were time to first self-reported recovery and admission to hospital/death related to COVID-19, within 28 days, analysed using Bayesian models. RESULTS: The trial opened on 2 April 2020. Randomisation to colchicine started on 4 March 2021 and stopped on 26 May 2021 because the prespecified time to recovery futility criterion was met. The primary analysis model included 2755 participants who were SARS-CoV-2 positive, randomised to colchicine (n = 156), usual care (n = 1145), and other treatments (n = 1454). Time to first self-reported recovery was similar in the colchicine group compared with usual care with an estimated hazard ratio of 0.92 (95% credible interval (CrI) = 0.72 to 1.16) and an estimated increase of 1.4 days in median time to self-reported recovery for colchicine versus usual care. The probability of meaningful benefit in time to recovery was very low at 1.8%. COVID-19-related admissions to hospital/deaths were similar in the colchicine group versus usual care, with an estimated odds ratio of 0.76 (95% CrI = 0.28 to 1.89) and an estimated difference of -0.4% (95% CrI = -2.7 to 2.4). CONCLUSION: Colchicine did not improve time to recovery in people at higher risk of complications with COVID-19 in the community.


Subject(s)
COVID-19 , Adult , Bayes Theorem , COVID-19/drug therapy , Colchicine/therapeutic use , Humans , Prospective Studies , SARS-CoV-2 , Treatment Outcome
7.
Sci Rep ; 12(1): 9208, 2022 06 02.
Article in English | MEDLINE | ID: covidwho-1873557

ABSTRACT

Some patients with COVID-19 pneumonia develop an associated cytokine storm syndrome that aggravates the pulmonary disease. These patients may benefit of anti-inflammatory treatment. The role of colchicine in hospitalized patients with COVID-19 pneumonia and established hyperinflammation remains unexplored. In a prospective, randomized controlled, observer-blinded endpoint, investigator-initiated trial, 240 hospitalized patients with COVID-19 pneumonia and established hyperinflammation were randomly allocated to receive oral colchicine or not. The primary efficacy outcome measure was a composite of non-invasive mechanical ventilation (CPAP or BiPAP), admission to the intensive care unit, invasive mechanical ventilation requirement or death. The composite primary outcome occurred in 19.3% of the total study population. The composite primary outcome was similar in the two arms (17% in colchicine group vs. 20.8% in the control group; p = 0.533) and the same applied to each of its individual components. Most patients received steroids (98%) and heparin (99%), with similar doses in both groups. In this trial, including adult patients with COVID-19 pneumonia and associated hyperinflammation, no clinical benefit was observed with short-course colchicine treatment beyond standard care regarding the combined outcome measurement of CPAP/BiPAP use, ICU admission, invasive mechanical ventilation or death (Funded by the Community of Madrid, EudraCT Number: 2020-001841-38; 26/04/2020).


Subject(s)
COVID-19 , Adult , COVID-19/complications , COVID-19/drug therapy , Colchicine/therapeutic use , Humans , Intensive Care Units , Prospective Studies , Respiration, Artificial
8.
Int J Rheum Dis ; 25(7): 787-794, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1868566

ABSTRACT

AIM: To determine frequency of adverse events and attacks related to vaccination in recipients of CoronaVac and BNT162b2 in familial Mediterranean fever (FMF) patients, and to search whether history of prior COVID-19 or a booster dose increases occurrence of adverse events/attacks. METHODS: FMF patients were surveyed for administration of any COVID-19 vaccine and vaccine-related adverse events or FMF attacks. Demographic, clinical, vaccine-related data, history of COVID-19 infection before or after vaccination, adherence to FMF treatment during vaccination were collected. RESULTS: A total of 161 vaccinated FMF patients were included. Ninety-three patients out of 161 had reported suffering from an adverse event/attack after a vaccine dose. There were 54.7% of BNT162b2 recipients who reported any adverse event after any vaccine dose in comparison to 29.9% of CoronaVac recipients (P < .001). There were 22.2% of BNT162b2 recipients who reported suffering from a FMF attack within 1 month after vaccination in comparison to 19.4% of CoronaVac recipients (P = .653). When patients with or without adverse event/attack were compared, no significant differences were observed in means of demographics, comorbid diseases, disease duration, total vaccine doses, or treatments adhered to for FMF. Rates of adverse events/attacks were similar between patients with and without prior COVID-19. In booster recipients, adverse events/attacks were most frequent after the booster dose. CONCLUSIONS: A considerable number of FMF patients suffered from vaccine-related adverse events/attacks, particularly with BNT162b2. No serious events or mortalities due to vaccination were detected. Demographics, clinical characteristics and prior history of vaccination did not significantly affect these results. We observed an increased rate of adverse events/attacks with booster dose administration.


Subject(s)
COVID-19 , Familial Mediterranean Fever , BNT162 Vaccine , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Colchicine/therapeutic use , Familial Mediterranean Fever/drug therapy , Humans
10.
PLoS One ; 17(4): e0266245, 2022.
Article in English | MEDLINE | ID: covidwho-1775456

ABSTRACT

BACKGROUND: Colchicine has been used an effective anti-inflammatory drug to treat gout diseases. Owing to its pharmacodynamic of inhibiting interleukins, it has been repurposed to target the cytokine storm post-SARS-CoV-2 invasion. The goal of this meta-analysis was to evaluate the safety profile of colchicine in COVID-19 patients using the gold-standard randomised-control trials. METHODS: Electronic databases (Pubmed, Google Scholar, and Cochrane) were systematically searched until June 2021 and RCTs were extracted. Outcomes of interest included all-cause mortality, COVID-19 severity, mechanical ventilation, C-reactive protein and D-dimer levels. Using a random-effects model, dichotomous outcomes were pooled using odds ratios (OR) through the generic inverse variance formula while weighted mean differences were calculated using the Wan's method. P-values < 0.05 were considered statistically significant for all outcomes. RESULTS: A total population of 16,048 from five RCTs were included in the analysis. Of this, 7957 were randomized to colchicine, and 8091 received standard care, with an average age of 60.67 years. Colchicine was observed to significantly reduce COVID-19 severity (OR: 0.41, 95% CI [0.22, 0.76]; p = 0.005), and CRP levels (WMD: -19.99, 95% CI [-32.09, -7.89]; p = 0.001). However, there was no significant difference in D-dimer levels (WMD: 0.31, 95% CI [-0.61, 1.23]; p = 0.51), mechanical ventilation (OR: 0.42, 95% CI [0.17, 1.03]; p = 0.06; I2 = 74%) and all-cause mortality (OR: 0.98, 95% CI [0.83, 1.16]; p = 0.84) among patients receiving colchicine or standard care. CONCLUSION: Colchicine treatment decreased CRP levels and COVID-19 severity, with dimer levels, all-cause mortality and mechanical ventilation remaining seemingly unaffected. Thus, clinical trials need to be carried out that allow effective evaluation of colchicine in COVID-19 patients.


Subject(s)
COVID-19 , Colchicine , C-Reactive Protein , COVID-19/drug therapy , Colchicine/therapeutic use , Humans , Middle Aged , Odds Ratio , Randomized Controlled Trials as Topic , Respiration, Artificial , SARS-CoV-2
11.
Expert Opin Pharmacother ; 23(6): 681-691, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1769033

ABSTRACT

INTRODUCTION: Aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are first-line treatments for acute and recurrent pericarditis. Drugs blocking the NACHT, leucine-rich repeat, and pyrin domain-containing protein 3 (NLRP3) inflammasome/interleukin-1ß (IL-1ß) axis are beneficial in patients with multiple recurrences. AREAS COVERED: In this review, the role of the NLRP3 inflammasome/IL-1ß axis in the pathophysiology of pericarditis is discussed. Updates about novel therapies targeting IL-1 for recurrent pericarditis (RP) and practical considerations for their use are provided. EXPERT OPINION: IL-1 inhibitors have been increasingly studied for RP in recent years. NLRP3 inflammasome is a key mediator in the pathophysiology of RP. IL-1ß, its main product, can sustain its own production and feeds local and systemic inflammation. Randomized clinical trials testing anakinra (a recombinant form of the IL-1 receptor antagonist blocking IL-1α and IL-1ß) and rilonacept (an IL-1α and IL-1ß trap) have shown that IL-1 blockade reduces recurrences. These trials also helped in phenotyping patients with RP. Patients with multiple recurrences and signs of pericardial and/or systemic inflammation might benefit from IL-1 blockers in order to interrupt cyclic flares of auto-inflammation. Given this evidence, guidelines should consider incorporating IL-1 blockers.


Subject(s)
Pericarditis , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Colchicine/therapeutic use , Humans , Inflammasomes/metabolism , Inflammasomes/therapeutic use , Inflammation/drug therapy , Pericarditis/diagnosis , Pericarditis/drug therapy
12.
J Med Virol ; 94(7): 3431-3437, 2022 07.
Article in English | MEDLINE | ID: covidwho-1750408

ABSTRACT

This study aimed to investigate whether patients regularly using colchicine or hydroxychloroquine (HCQ) have an advantage of protection from coronavirus disease 2019 (COVID-19) or developing less severe disease. Patients who were taking colchicine or HCQ regularly for a rheumatic disease including Familial Mediterranean Fever, Behçet's syndrome, Systemic Lupus Erythematosus, Rheumatoid Arthritis, and Sjogren's syndrome, as well as their healthy household contacts as the control group, were included in the study. The clinical data regarding COVID-19 were collected using a standard form, and serum samples were analyzed for anti-severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) nucleocapsid immunoglobulin G (IgG). A total of 635 regular colchicine users with their 643 household contacts and 317 regular HCQ users with their 333 household contacts were analyzed. Anti-SARS-COV-2 IgG was positive in 43 (6.8%) regular colchicine users and 35 (5.4%) household contacts (odds ratio [OR] = 1.3; 95% confidence interval [CI]:0.8-2; p = 0.3). COVID-19-related symptoms were described by 29 (67.4%) of the patients and 17 (48.6%) household contacts (OR = 2.2; 95% CI :0.9-5.5; p = 0.09), and hospital admission was observed in five (11.6%) and one (2.9%) of these subjects (OR = 4.5; 95% CI: 0.5-40.2; p = 0.1), respectively. Seropositive subjects were observed in 22 (6.9%) regular HCQ users and 24 (7.2%) household contacts (OR = 1.1; 95% CI: 0.6-1.9; p = 0.8). COVID-19-related symptoms occurred in 16 (72.7%) of the 22 patients and 12 (50%) of 24 household contacts (OR = 2.7; 95% CI: 0.8-9.1; p = 0.1). Three patients (13.6%) were admitted to hospital, while one household contact (4.2%) was hospitalized (OR = 3.6; 95% CI: 0.3-37.8; p = 0.2). Being on a regular treatment of colchicine or HCQ did not result in the prevention of COVID-19 or amelioration of its manifestations.


Subject(s)
COVID-19 , Rheumatic Diseases , COVID-19/drug therapy , Colchicine/therapeutic use , Humans , Hydroxychloroquine/therapeutic use , Immunoglobulin G , Rheumatic Diseases/drug therapy , SARS-CoV-2
13.
Ann Rheum Dis ; 81(8): 1189-1193, 2022 08.
Article in English | MEDLINE | ID: covidwho-1741595

ABSTRACT

OBJECTIVES: COVID-19 vaccination often triggers a constellation of transitory inflammatory symptoms. Gout is associated with several comorbidities linked to poor outcomes in COVID-19, and gout flares can be triggered by some vaccinations. We analysed the risk of gout flares in the first 3 months after COVID-19 vaccination with inactivated virus, and whether colchicine can prevent gout flares following post-COVID-19 vaccination. METHODS: A clinical delivery population-based cross-sectional study was conducted in the Gout Clinic at the Affiliated Hospital of Qingdao University between February and October 2021. Study participants were selected using a systematic random sampling technique among follow-up patients with gout. We collected data, including vaccinations and potential risk factors, using a combination of interviews, health QR codes and medical records. Logistic regression was used to adjust for covariates. RESULTS: We enrolled 549 gout participants (median age 39 years, 84.2% vaccinated). For the 462 patients who received COVID-19 vaccine, 203 (43.9%) developed at least one gout flare in the 3 months after vaccination. Most of these flares were experienced within 1 month after the first (99/119 (83.2%)) or second (70/115 (60.9%)) dose of vaccine. Compared with unvaccinated participants, COVID-19 vaccination was associated with higher odds of gout flare within 3 months (adjusted OR 6.02; 95% CI 3.00 to 12.08). Colchicine use was associated with 47% less likelihood of postvaccine gout flare. CONCLUSION: COVID-19 vaccination was associated with increased odds of gout flare, which developed mainly in month 1 after each vaccine dose, and was negatively associated with colchicine prophylaxis.


Subject(s)
COVID-19 Vaccines , COVID-19 , Colchicine , Gout Suppressants , Gout , Symptom Flare Up , Adult , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Colchicine/therapeutic use , Cross-Sectional Studies , Gout/drug therapy , Gout Suppressants/therapeutic use , Humans , Vaccination , Vaccines/therapeutic use
14.
15.
Ann Med ; 54(1): 775-789, 2022 12.
Article in English | MEDLINE | ID: covidwho-1730419

ABSTRACT

INTRODUCTION: Colchicine, because of its anti-inflammatory and possible anti-viral properties, has been proposed as potential therapeutic option for COVID-19. The role of colchicine to mitigate "cytokine storm" and to decrease the severity and mortality associated with COVID-19 has been evaluated in many studies. OBJECTIVE: To evaluate the role of colchicine on morbidity and mortality in COVID-19 patients. METHODS: This systematic review was conducted in accordance with the PRISMA recommendations. The literature search was conducted in 6 medical databases from inception to February 17, 2021 to identify studies evaluating colchicine as a therapeutic agent in COVID-19. All included studies were evaluated for risk of bias (ROB) using the Revised Cochrane ROB tool for randomised controlled trials (RCTs) and Newcastle-Ottawa Scale (NOS) for case-control and cohort studies. RESULTS: Four RCTs and four observational studies were included in the final analysis. One study evaluated colchicine in outpatients, while all others evaluated inpatient use of colchicine. There was significant variability in treatment protocols for colchicine and standard of care in all studies. A statistically significant decrease in all-cause mortality was observed in three observational studies. The risk of mechanical ventilation was significantly reduced only in one observational study. Length of hospitalisation was significantly reduced in two RCTs. Risk for hospitalisation was not significantly decreased in the study evaluating colchicine in outpatients. Very few studies had low risk of bias. CONCLUSION: Based on the available data, colchicine shall not be recommended to treat COVID-19. Further high-quality and multi-center RCTs are required to assess the meaningful impact of this drug in COVID-19.KEY MESSAGESColchicine, an anti-inflammatory agent has demonstrated anti-viral properties in in-vitro studies by degrading the microtubules, as well as by inhibiting the production of pro-inflammatory cytokines.Colchicine has been studied as a potential therapeutic option for COVID-19, with variable results.Until further research can establish the efficacy of colchicine in COVID-19, the use of colchicine in COVID-19 shall be restricted to clinical trials.


Subject(s)
COVID-19 , COVID-19/drug therapy , Colchicine/therapeutic use , Humans , Morbidity , Observational Studies as Topic , Respiration, Artificial , SARS-CoV-2
16.
Inflamm Res ; 71(3): 293-307, 2022 Mar.
Article in English | MEDLINE | ID: covidwho-1729272

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is capable of inducing the activation of NACHT, leucine-rich repeat, and pyrin domain-containing protein 3 (NLRP3) inflammasome, a macromolecular structure sensing the danger and amplifying the inflammatory response. The main product processed by NLRP3 inflammasome is interleukin (IL)-1ß, responsible for the downstream production of IL-6, which has been recognized as an important mediator in coronavirus disease 2019 (COVID-19). Since colchicine is an anti-inflammatory drug with the ability to block NLRP3 inflammasome oligomerization, this may prevent the release of active IL-1ß and block the detrimental effects of downstream cytokines, i.e. IL-6. To date, few randomized clinical trials and many observational studies with colchicine have been conducted, showing interesting signals. As colchicine is a nonspecific inhibitor of the NLRP3 inflammasome, compounds specifically blocking this molecule might provide increased advantages in reducing the inflammatory burden and its related clinical manifestations. This may occur through a selective blockade of different steps preceding NLRP3 inflammasome oligomerization as well as through a reduced release of the main cytokines (IL-1ß and IL-18). Since most evidence is based on observational studies, definitive conclusion cannot be drawn and additional studies are needed to confirm preliminary results and further dissect how colchicine and other NLRP3 inhibitors reduce the inflammatory burden and evaluate the timing and duration of treatment.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , COVID-19/drug therapy , Colchicine/therapeutic use , Inflammasomes/immunology , NLR Family, Pyrin Domain-Containing 3 Protein/immunology , SARS-CoV-2 , Animals , COVID-19/immunology , Humans
17.
J Infect Dev Ctries ; 16(1): 57-62, 2022 Jan 31.
Article in English | MEDLINE | ID: covidwho-1705131

ABSTRACT

INTRODUCTION: Colchicine is an ancient agent with well-known anti-inflammatory effects and commonly used in treatment of hyperinflammatory conditions. It has been argued that colchicine could be an appropriate treatment option in COVID-19 to control hyperinflammatory response. Here in this study, we aimed to investigate the impact of colchicine on outcomes of COVID-19 in our inpatient cohort. METHODOLOGY: In this retrospective cohort study, hospitalized COVID-19 patients were investigated. Demographics, comorbidities, COVID-19 symptoms, laboratory findings on admission and discharge, baseline and seventh day oxygenation status, rates of mortality, intensive care unit admission, administration of other anti-inflammatory treatments and length of hospital stay were compared between patients who received standard of care medications and who received colchicine additionally. RESULTS: Three hundred and thirty-six patients were included in the study (171 standard of care, 165 standard of care plus colchicine). The median length of hospital stay in colchicine group was significantly shorter. Rates of admission to intensive care unit, anti-inflammatory treatment administration and mortality did not differentiate between standard of care and colchicine groups. However, reduced rates of mortality and ICU admission were observed in patients who received colchicine with a dose of 1 mg/day when compared to patients who received 0.5 mg/day. CONCLUSIONS: Our study demonstrated that COVID-19 patients who received colchicine in addition to standard of care had shorter hospital stay. Our results further support the use of colchicine in treatment of COVID-19, particularly with a dose of 1 mg/day.


Subject(s)
COVID-19 , Colchicine , Colchicine/therapeutic use , Hospitalization , Humans , Intensive Care Units , Length of Stay , Retrospective Studies , SARS-CoV-2
18.
Eur J Intern Med ; 96: 34-41, 2022 02.
Article in English | MEDLINE | ID: covidwho-1670444

ABSTRACT

Colchicine is an old, inexpensive, and relatively safe anti-inflammatory drug traditionally used in gout and over the last 50 years in familial Mediterranean fever. A search of all high-hierarchy studies (randomized controlled trials [RCTs], systematic reviews and meta-analysis of RCTs) over the last 20 years revealed myriad other evidence-based applications. Colchicine seems efficacious in the treatment of acute pericarditis and prevention of recurrences and in the prevention of postcardiac injury syndrome and atrial fibrillation following cardiac surgery or percutaneous interventions. In patients already fully treated with statins and antiplatelet agents following acute coronary syndromes or stable coronary disease, adding low-dose colchicine achieved secondary prevention of major cardiovascular events (myocardial infarction, stroke, or cardiovascular death) with pooled risk reduction 0.75. Colchicine may also be useful in Behcet's syndrome and most recently, in improving outcomes of COVID-19 infection. Colchicine in the low doses used in most trials (≤ 1 mg/d) was generally safe and well-tolerated, excepting diarrhea (approximately 10%) which sometimes led to drug discontinuation. Further RCTs are required to confirm these results, and will likely lead to expanding indications for low-dose colchicine. Increasing numbers of patients will be treated with colchicine in the near future, with improved health outcomes, as long as basic caveats are heeded.


Subject(s)
Acute Coronary Syndrome , COVID-19 , Pharmaceutical Preparations , Colchicine/therapeutic use , Humans , SARS-CoV-2
19.
Med Clin (Barc) ; 159(6): 262-267, 2022 09 23.
Article in English, Spanish | MEDLINE | ID: covidwho-1670882

ABSTRACT

OBJECTIVE: The implications of Covid-19 in patients with Behçet's disease (BD) are unknown. Patients with BD usually take long-term therapy with therapeutic agents that have been tested in Covid-19 patients. We aimed to assess the prevalence of Covid-19 in a cohort of patients with BD and investigate whether those patients with a long-term treatment with colchicine, tumor necrosis factor inhibitors (TNFi) or glucocorticoids are at reduced or increased prevalence of Covid-19 related clinical outcomes. METHODS: A retrospective study was conducted among 244 patients with BD (86.1% females; mean age 43.95±11.11 years). Each participant completed an online questionnaire regarding demographics, medical conditions, dispensed colchicine, TNFi or oral glucocorticoids, Covid-19 infection, clinical symptoms and recovery. RESULTS: The prevalence of Covid-19 infection was 14.75%. Regarding dose of colchicine, the presence of ageusia was lower in patients taking 0.5mg/day of colchicine compared to those taking 1.5mg/day (p=0.021). The prevalence of dyspnea was significantly higher in patients taking TNFi compared with those without therapy (p=0.032). With regards to oral glucocorticoids, no significant differences were found. CONCLUSIONS: The prevalence of Covid-19 among patients with BD seems to be higher than that among the general population in Spain. Continuous TNFi therapy might increase the prevalence of worse clinical outcomes such as dyspnea; oral glucocorticoids and colchicine apparently provided no protection against the Covid-19 related clinical outcomes of patients with BD.


Subject(s)
Behcet Syndrome , COVID-19 , Adult , Behcet Syndrome/complications , Behcet Syndrome/drug therapy , Behcet Syndrome/epidemiology , Colchicine/therapeutic use , Dyspnea/etiology , Female , Glucocorticoids/therapeutic use , Humans , Male , Middle Aged , Retrospective Studies , Tumor Necrosis Factor Inhibitors
20.
BMJ Case Rep ; 15(1)2022 Jan 21.
Article in English | MEDLINE | ID: covidwho-1642829

ABSTRACT

COVID 19, caused by SARS-CoV-2, is a highly infectious disease, mainly affects the respiratory system. In this article, we have presented a case of COVID-19, who presented solely with pericarditis without myocarditis, without any respiratory symptoms. The diagnosis was made based on clinical, electrocardiographic, radiological and biological findings. He was treated successfully with aspirin and colchicine. Our case highlights an atypical presentation of COVID-19, which should be kept in mind in the present pandemic and to diagnose and isolate early to limit the spread of infection.


Subject(s)
COVID-19 , Pericarditis , Colchicine/therapeutic use , Humans , Male , Pandemics , Pericarditis/diagnosis , Pericarditis/drug therapy , SARS-CoV-2
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