Ulcerative colitis in a transgender woman with a sigmoid neovagina: a case report.

BACKGROUND: Sex reassignment surgery (SRS) is a necessary step in transitioning into the desired gender for male-to-female transgender individuals. This study focuses on a rare complication developed following SRS, aiming to highlight potential complications associated with this procedure. CASE PRESENTATION: This report describes a 49-year-old transgender woman with a history of SRS who developed bloody diarrhea and neovaginal bleeding 10 years later. A colonoscopy revealed features compatible with ulcerative colitis, which was confirmed by a biopsy. CONCLUSIONS: The unpredictable clinical course of this phenomenon may prompt surgeons to reconsider the use of a rectosigmoid colon to create a neovagina. This case report underscores the necessity of long-term monitoring for gastrointestinal complications in transgender women post-SRS when a rectosigmoid colon segment is utilized for neovaginal construction.

Prevalence and risk factors of gastroesophageal reflux disease in Iran: A cross-sectional analysis from the PERSIAN cohort.

BACKGROUND: This study assessed the prevalence of gastroesophageal reflux disease (GERD) in a general adult population in Iran. The association between GERD and various factors was also evaluated. METHODS: We performed a cross-sectional study on 163,018 individuals aged over 35 who were enrolled in the PERSIAN cohort. GERD was defined as the occurrence of heartburn and/or regurgitation symptoms at least several days a month. Survey design analysis for pooled data was performed and multiple regression analysis was conducted to determine the independent risk factors for GERD. RESULTS: The prevalence of GERD in our study was estimated at 21.86% (95% confidence interval:17.4%-36.4%). The mean age of the participants was 49.84 years±9.25 (35-70) and 44.75% of the participants were male. Symptoms of heartburn and regurgitation were reported in 18.65% (n: 29,170) and 6.06% (n: 9,717) of participants, respectively. In the multivariate analysis, several factors were found to be associated with a higher prevalence of GERD: female sex, age >50, current smoking, opium use, weekly consumption of fried foods, frequent consumption of hot tea, less than 6 hours of sleep per night, psychiatric disorders, usage of NSAIDs, and poor oral hygiene, were associated with a higher prevalence of GERD. Conversely, higher education levels and average physical activity were found to be less commonly associated with GERD. CONCLUSION: We found a relatively high prevalence of GERD (21.86%) in this population-based study in Iran. By identifying modifiable risk factors, this research offers opportunities for targeted interventions and lifestyle modifications to reduce the burden of GERD.

The experiences of psychiatric patients, their caregivers and companions in upholding patient dignity during hospitalization: A qualitative study.

INTRODUCTION: The quality of care and patient satisfaction is closely linked with dignity, which is a crucial component of therapy and care. However, there is very little study on dignity in the context of mental health care. Planning for ongoing patient care might benefit from an understanding of the notion of dignity by exploring the experiences of patients, caregivers and companions of patients who have a history of hospitalization in mental health institutions. To retain patients' dignity while they were being treated in mental wards, this study sought to understand the experiences of patients, caregivers and companions of patients. MATERIALS AND METHODS: This investigation was qualitative. Semistructured interviews and focus groups were utilized to collect the data. The purposeful sampling method was employed for participant recruitment, which continued until data saturation. Two focus group discussions and 27 interviews were conducted. Participants included 8 patients, 2 patients' family members (companions), 3 psychologists, 4 nurses and 11 psychiatrists. Two focus group discussions were held with seven family members or companions of patients. Thematic analysis was used for data analysis. RESULTS: The primary theme that emerged was the infringement of patients' dignity, through negative guardianship, dehumanization and violations of their rights. Subthemes included dehumanization, worthlessness and namelessness, patient rights violations and stripping patients of authority. CONCLUSION: Our results suggest that, regardless of the severity of the illness, the nature of psychiatric illness significantly compromises patients' dignity. Mental health practitioners, due to their sense of guardianship, may unintentionally treat patients with mental health disorders, thus compromising the patient's dignity. PATIENT OR PUBLIC CONTRIBUTION: The research team's experiences as a psychiatrist, doctor and nurse informed the study's objectives. Nurses and psychiatrists who work in the healthcare industry designed and conducted the study. The primary authors, who are healthcare providers, collected and analysed the required data. Furthermore, the entire study team contributed to the writing of the manuscript. Study participants were involved in the data collection and analysis.

Opium Effects on Pancreatobiliary System in Opium Abusers Evaluated by Endoscopic Ultrasonography.

Background: Opium use is a significant social and public health issue. There are numerous effects of opium documented as affecting the pancreatobiliary system. The aim of the study was to assess the pancreatobiliary changes in patients with opium addiction by endoscopic ultrasonography (EUS). Methods: During the study period, consecutive patients who were referred for EUS of submucosal upper gastrointestinal lesions were included. The history of opium addiction and clinical symptoms were recorded prospectively. Diameters of the common bile duct (CBD), pancreatic duct (PD), size of the ampulla of Vater, and gallbladder abnormalities were evaluated using EUS. Results: A total of 254 patients (53.1% male, mean age of 55.4±14.2 years) were studied. A history of opium addiction was present in 56 patients (22.0%). Choledocholithiasis was found in two patients (3.6%) and one control (0.5%) patient (P=0.06). Gallbladder stones were found in 13 opium-addict (23.2%) and 16 control (8.1%) patients (P=0.002). The mean diameter of the CBD, size of the ampulla of Vater (P<0.001), and PD (P=0.04) were all significantly greater in patients with opium addiction. Conclusion: Dilation of the biliary and PDs is seen more commonly in patients addicted to opium. However, the clinical implications of these findings need to be further evaluated in future studies.

Comparison between the Efficacy and Tolerability of Polyvinylpyrrolidone-Iodine Eye Drops 0.6% and 1% in Adenoviral Keratoconjunctivitis: A Randomized Clinical Trial.

Purpose: To investigate the effect of topical Polyvinylpyrrolidone-iodine (PVP-I) 0.6% on the clinical course of adenoviral keratoconjunctivitis compared with PVP-I 1% and artificial tears. Methods: We prospectively enrolled all patients over 18 years of age with a polymerase chain reaction (PCR)-confirmed diagnosis of adenoviral keratoconjunctivitis who presented to the hospital between November 2022 and June 2023. Patients were randomized into 3 groups: artificial tears (control), PVP-I 1%, and PVP-I 0.6% eye drops, 4 times daily for 5 days. Clinical signs at presentation and at 6 follow-up visits during the 1st 3 weeks of the acute phase were recorded. Patients were also followed up at 1 and 3 months. Results: Ninety-four patients completed the study, of which 30, 31, and 33 were in the control, PVP-I 1%, and PVP-I 0.6% groups, respectively. The mean age of the patients was 37.2 years (interquartile range: 25-46). The PCR result was positive in 75.6% of patients with the clinical suspicion. PVP-I, regardless of the concentration, was superior to the artificial tears in terms of time to resolution of lid swelling, discharge, and incidence of subsequent subepithelial infiltrates (P < 0.05). However, a concentration of 0.6% was equivalent to 1%. No significant adverse events were reported in any group. Conclusions: The PVP-I 0.6% topical drops are safe and well tolerated in patients with acute adenoviral keratoconjunctivitis. It can be substituted for the 1% solution as it has comparable effects in improving the clinical course and reducing subsequent complications.

Cardio-Pulmonary Histopathology with Clinical Correlations of Deceased Patients with COVID-19: A Case Series in Tehran, Iran.

BACKGROUND: SARS-CoV-2 may affect vital organs. The present study investigated the histopathology of pulmonary and cardiac tissues with clinical correlation in deceased patients with COVID-19. METHODS: We obtained pulmonary and cardiac tissues from 30 deceased patients with COVID-19 in Tehran, Iran, from January to May 2021. Sampling was performed through a percutaneous needle biopsy. After slide preparation, two expert pathologists studied them. We assessed the correlation between clinical and pathological data by Fisher's exact test. RESULTS: The mean age of the patients was 73.8±13.4 years, and the male-to-female ratio was 23/7. The most common underlying disease was hypertension (HTN) in 25 patients (83%). Fifty-five tissue samples were achieved, including 28 pulmonary and 27 cardiac samples. Our results showed that all patients (100%) developed diffuse alveolar damage (DAD), and 26 (93%) developed hyaline membrane formation. The most common phase of DAD was the exudative-proliferative phase in 16 (57.1%). Three cardiac samples (11%) revealed myocarditis, and seven (26%) showed cardiomyocyte hypertrophy. In univariate analysis using Fischer's exact test, myocarditis had significant relationships with C-reactive protein (CRP) levels higher than 80 mg/dL (P=0.008) and elevated cardiac troponin levels higher than two-fold (P=0.01). CONCLUSION: COVID-19 can affect the major vital organs. However, only myocarditis had a significant relationship with the circulating levels of inflammatory factors.

Efficacy of a standardized herbal formulation from Glycyrrhiza glabra L. as an adjuvant treatment in hospitalized patients with COVID-19: A Randomized Controlled trial.

Introduction: As no specific pharmacological intervention has been known for COVID-19, medicinal plants may be a suitable candidate for management of this disease. The aim of this study was to investigate the efficacy of a herbal syrup from licorice as an adjuvant treatment in hospitalized patients with COVID-19. Materials and methods: 213 hospitalized patients diagnosed with COVID-19 were assigned to receive either standardized licorice syrup as an adjuvant treatment plus standard care [Syrup Group (SYRUP), N = 91], or standard care alone [Standard Group (STANDARD), N = 104], for 7 days. The primary endpoint was duration of hospitalization in survivors. The secondary endpoints included 25% increase in oxygen saturation, C-reactive protein (CRP) difference and lymphocyte difference from baseline, number of death and number of patients transferred to ICU. Results: Mean duration of admission was 5.24 days in SYRUP and 7.14 days in STANDARD (p < 0.001). Oxygen saturation increased in 86 of 91 patients (94.5%) in the licorice group, compared to 83 of 104 patients (79.8%) in the control group (p = 0.002). There was no significant difference between the two groups in the number of patients died during hospitalization (p = 0.837). Five patients in SYRUP and 16 patients in STANDARD were transferred to ICU (p < 0.026). Mean reduction in CRP (p < 0.001) and mean increase in the number of lymphocytes (p = 0.008) in SYRUP were significantly higher than STANDARD. Discussion: Licorice syrup as an adjuvant treatment demonstrated promising results on duration of hospital admission, O2 saturation as well as inflammatory markers in COVID-19 patients; however, further clinical studies with larger sample size are suggested to achieve more conclusive results.

Association of Echocardiographic Findings with in-Hospital Mortality of COVID-19 Patients and Their Changes in One-Month Follow-Up; a Cohort Study.

Introduction: Evidence showed that cardiac complications may occur in coronavirus disease-19 (COVID-19) during the acute and post-infection phases. This study aimed to evaluate the association between the echocardiographic characteristics and in-hospital mortality of COVID-19 patients as well as the changes after one-month follow-up. Method: All adult (≥18 years old) hospitalized COVID-19 patients in need of echocardiography based on the guideline of the Iranian Society of Echocardiography for performing various types of echocardiography during the COVID-19 pandemic were included in this study. An expert cardiologist performed the echocardiography on all patients and also on all available patients one month after discharge. Results: 146 hospitalized cases of COVID-19 and 81 cases available for 1-month follow-up echocardiography were studied in this prospective study. Left ventricle wall hypokinesia, aorta valve stenosis, dilated Inferior Vena Cava (IVC), and Pulmonary Artery Systolic Pressure (PASP) of more than 35 were associated with 3.59 (95% CI: 1.19-10.79, p = 0.02), 11 (95% CI: 3.3 - 36.63, p = 0.001), 5.58 (95% CI: 1.04-29.41, p = 0.041) , and 2.91 (95% CI: 1.35 - 6.3, p = 0.001) times higher odds of mortality than healthy subjects. In 1-month follow-up of patients, deterioration in LVEF (p = 0.03) was detected in the not-fully vaccinated patients, and a significant decrease in PASP was observed in all cases (p = 0.04); but these changes were not clinically important. Conclusion: Left ventricle wall hypokinesia, aorta valve stenosis, dilated IVC, and PASP ≥ 35 were predictors of in-hospital mortality in our study. There were not any potential clinically significant differences in one-month echocardiographic follow-ups of the studied patients.

Efficacy and safety of acetylcysteine for the prevention of liver injury in COVID-19 intensive care unit patients under treatment with remdesivir.

Aim: The present double-blinded placebo-controlled randomized clinical trial evaluated prophylactic use of acetylcysteine for the prevention of liver injury in patients with severe COVID-19 pneumonia under treatment with remdesivir. Background: Liver injury is reportedly common in patients with severe COVID-19 pneumonia and can occur not only as a result of disease progression, but as an iatrogenic reaction to remdesivir. Methods: A total of 83 adult patients with severe COVID-19 pneumonia were randomly assigned in parallel groups to receive either acetylcysteine or placebo. All the patients received standard care according to institutional protocols, including remdesivir for a total of five days. One gram acetylcysteine was administered intravenously every 12 hours for 42 patients, and 41 patients received the same volume of 0.9% sodium chloride as placebo (Trial Registration: www.irct.ir identifier, IRCT20210726051995N1). Results: After 5 days, median aspartate transaminase (AST) and alanine transaminase (ALT) levels were significantly lower in the acetylcysteine than in the placebo group. Of those who received the placebo, 30 (73.2%), 4 (9.7%), and 3 (7.3%) patients had serum AST levels elevated between 1-2.5, 2.5-5, and over 5 times the upper limit of normal (ULN), respectively; while in the acetylcysteine group, 33 (78.6%) and 0 patients had AST levels between 1-2.5 and over 2.5 times ULN, respectively (p-value=0.037). In the acetylcysteine group, 23 (54.8%), 1 (2.4%), and 1 (2.4%) patient had serum ALT levels elevated between 1-2.5, 2.5-5, and over 5 times ULN, respectively; in the placebo group, however, 24 (58.5%), 7 (17.1%), and 1 (2.4%) patient had serum ALT levels between 1-2.5, 2.5-5, and over 5 times ULN, respectively (p-value=0.073). Conclusion: Intravenous administration of acetylcysteine significantly prevents liver transaminases elevation and liver injury in seriously ill COVID-19 patients treated with remdesivir.

Immunological evaluation of patients with 2019 novel coronavirus pneumonia: CD4+ and CD16+ cells may predict severity and prognosis.

PURPOSE: Available but insufficient evidence shows that changes may occur in the immune system following coronavirus disease 2019 (COVID-19). The present study aimed at evaluating immunological changes in patients with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pneumonia compared with the control group. METHOD: The present study was performed on 95 patients with COVID-19 (32 severe and 63 moderate cases) and 22 healthy controls. Relationship between immune cells, disease severity and lung involvement was assessed. Binary logistic regression and ROC curve tests were used for statistical analysis. RESULTS: A significant decrease was observed in CD20+ cell counts of the patients. To differentiate patients from healthy individuals, the cutoff point for the CD4+ cell count was 688 /µL, sensitivity 0.96, and specificity 0.84. An increase in CD4+ cells reduces the odds of severe disease (odds ratio = 0.82, P = 0.047) and death (odds ratio = 0.74, P = 0.029). CD4+ cells play a pivotal role in the severity of lung involvement (P = 0.03). In addition to CD4+ cells, Fc gamma receptor III (FcγRIII) (CD16) also played a significant prognosis (odds ratio = 0.55, P = 0.047). In severe cases, C-reactive protein, Blood urea nitrogen, and Creatine phosphokinase levels, as well as neutrophil counts, were significantly higher than those of moderate ones whereas lymphocyte count in severe cases was lower than that of moderate ones. CONCLUSION: The number of total T-cells and B-cells in patients with COVID-19 was lower than that of controls; however, their NK cells increased. FcγRIII and CD4+ cells are of great importance due to their association with COVID-19 prognosis.

Thalamic hemi-chorea: a rare complication after receiving the adenoviral vector-based COVID-19 vaccine: a case report.

Lacunar strokes occur when a branch of a large cerebral artery is blocked. The thalamus is often affected, causing uncontrollable motions. A 72-year-old previously healthy man presented with involuntary motions in the right limbs, which were present at rest, and exacerbated during voluntary actions. He had received the first dose of the adenoviral vector-based coronavirus disease 2019 vaccine (ChAdOx1 nCoV-19) 9 days ago. Severe thrombocytopenia and elevated levels of lactate dehydrogenase, ferritin, C-reactive protein, and D-dimer were found, without any evidence of connective tissue disease. Electromyography demonstrated typical choreiform movements, and the brain magnetic resonance imaging indicated a small high signal lesion on the left side of the thalamus. Detection of the immunoglobulin G antibodies against platelet factor 4 in the blood, negative heparin-induced platelet activation (HIPA) test, and positive modified HIPA test confirmed the thalamic stroke due to the vaccine-induced prothrombotic immune thrombocytopenia (VIPIT). He was admitted to the intensive care unit and received nadroparin, sodium ozagrel, edaravone, methylprednisolone, and haloperidol. His hemi-chorea improved gradually over 2 weeks, and he was discharged after 21 days with rehabilitation advice. VIPIT due to the ChAdOx1 nCoV-19 is a novel immune-mediated response that needs clinicians' awareness and further investigations.

Efficacy of Red Blood Cell Exchange as Adjunctive Treatment for Hypoxemia and Survival Rate of Patients With Severe Coronavirus-2 Disease: An Open-Labeled Phase 2 Randomized Clinical Trial.

Background: Severe acute respiratory syndrome (SARS) coronavirus-2 may infect red blood cells (RBCs) and impact oxygenation. We aimed to evaluate the efficacy of RBC exchange as an adjunctive treatment for hypoxemia and the survival rate of patients with severe coronavirus disease 2019 (COVID-19). Methods: In a randomized clinical trial, we divided sixty patients with severe COVID-19 into two groups. The intervention group received the standard treatment of severe COVID-19 with RBC exchange three to four times in 2 days. The control group only received the standard treatment. Our primary outcomes were improving hypoxemia in 7 days, recovery or discharge, and death in 28 days. We conducted Chi-square test, independent samples t-test, and Fisher's exact test to analyze the results. The ethical committee of Aja University of Medical Sciences approved the study (IR.AJAUMS.REC.1399.054), and the Iranian clinical trial registration organization registered it (IRCT20160316027081N2). Results: Twenty-nine men and thirty-one women with a mean age of 67.5 years entered the study. The frequency of hypertension and diabetes mellitus was 86.7 and 68.3%, respectively. The most common symptoms of severe COVID-19 were dyspnea (91.6%), cough (75%), and fever (66.6%). Our results showed that hypoxemia improved in 21 of the 30 patients (70%) in the intervention group and 10 of the 30 patients (33.3%) in the control group (P < 0.004). The recovery and discharge rates were 19 of 30 patients (63.3%) in the intervention group and 2 of 30 patients (6.7%) in the control group (P < 0.001). Conclusion: The RBC exchange improved the oxygenation and survival rate in patients with severe COVID-19.

Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER).

BACKGROUND: The combination of sofosbuvir and daclatasvir has shown preliminary efficacy for hospitalized patients with COVID-19 in four open-label studies with small sample sizes. This larger trial aimed to assess if the addition of sofosbuvir/daclatasvir to standard care improved clinical outcomes in hospitalized patients with COVID-19. METHODS: This was a placebo-controlled, double-blind, randomized clinical trial in adults hospitalized with COVID-19 at 19 hospitals in Iran. Patients were randomized to oral sofosbuvir/daclatasvir 400/60 mg once-daily or placebo in addition to standard of care. Patients were included if they had positive PCR or diagnostic chest CT, O2 saturation <95% and compatible symptoms. The primary outcome was hospital discharge within 10 days of randomization. Secondary outcomes included mortality and time to clinical events. The trial is registered on the Iran Registry of Clinical Trials under IRCT20200624047908N1. RESULTS: Between July and October 2020, 1083 patients were randomized to either the sofosbuvir/daclatasvir arm (n = 541) or the placebo arm (n = 542). No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95-1.08, P = 0.734]. In-hospital mortality was 60/541 (11%) in the sofosbuvir/daclatasvir arm versus 55/542 (10%) in the placebo arm (RR 1.09, 95% CI 0.77-1.54, P = 0.615). No differences were observed in time to hospital discharge or time to in-hospital mortality. CONCLUSIONS: We observed no significant effect of sofosbuvir/daclatasvir versus placebo on hospital discharge or survival in hospitalized COVID-19 patients.

Colonoscopy Complications in an Iranian Teaching Hospital.

BACKGROUND: Colonoscopy is generally a safe procedure with a limited number of adverse events. Few studies have addressed the rate of adverse events in teaching hospitals. This study aimed to investigate the rate of complications after colonoscopy performed by gastroenterology fellows in a teaching hospital in Tehran. METHODS: A historical cohort study was carried out to link the colonoscopy reports and the hospital information system to identify serious adverse events leading to unplanned hospitalization, unplanned procedures or interventions (e.g. surgery), prolongation of existing hospitalization, or death within 30 days after colonoscopy. RESULTS: We included 9928 colonoscopies (mean age of the patients 53.0±15.9 years, 52.3% men) in this study. In-hospital patients comprised (34.8%) of the procedures. The indications of colonoscopy included 7137 diagnostic (71.9%), and 2519 screening (25.4%) reasons. Colorectal polyps were found in 2005 (20.2%) patients. Major complications were seen in 17 patients (0.2%), including serious bleeding in seven patients, cardiopulmonary complications in five patients, perforation in four patients, and sepsis in one patient. CONCLUSION: Serious adverse events after colonoscopy are relatively rare. The rate of complications does not appear to be higher in an academic teaching hospital when performed by fellows under supervision.

Validating the Self-assessed Wisdom Scale (SAWS) in an Iranian Sample: Psychometric and Developmental Findings.

This study aimed to investigate the validity and factor structure of the Self-Assessed Wisdom Scale (SAWS; Webster in J Adult Dev 10:13-22, 2003) in an Iranian population. Participants (235 male, 340 female) were recruited in Tehran, Iran and ranged in age from 17 to 88 years. Cronbach alpha's for the subscales ranged from .63 to .81, and their inter-correlations ranged from .42 to .53. Exploratory factor analysis extracted 5 factors that were similar with the original structure. Confirmatory factor analysis supported 5-factor model of the SAWS. The SAWS's total and subscale scores positively correlated with two other measures of wisdom (indicating convergent validity). The SAWS correlated weakly with age. Women scored higher in the SAWS subscales of emotional regulation, reminiscence/reflectiveness, and humor, which accounted for a significant gender difference in total wisdom. Although the age differences are consistent with prior research, the gender differences are relatively novel. Overall, results indicate that the SAWS has excellent psychometric properties and can be used in cross-cultural work.

Expression of RND efflux pumps mediated antibiotic resistance in Pseudomonas aeruginosa clinical strains.

Resistance-Nodulation-Division (RND) efflux pumps are responsible for multidrug resistance in Pseudomonas aeruginosa. The present study aimed to evaluate the overexpression of RND efflux pumps and its role in the antibiotic resistance of P. aeruginosa clinical isolates. A number of 122 isolates were obtained from three military hospitals in Tehran, Iran. In order to determine the antibiotic resistance, the isolates were identified and assessed by the disk diffusion and agar dilution methods. This study investigated the gene expression of four multi-drug efflux pump systems (MexAB-OprM, MexCD-OprJ, MexEF-OprN and MexXY (-OprA)) and its correlation with antibiotic resistance. The isolates indicated that the highest resistance rate was against ticarcillin (80%), followed by ciprofloxacin (74%) and meropenem (71%). Most of them expressed mexB (69%), mexC (28.7%), mexE (43.4%), and mexY (74.6%), suggesting that mexB and mexY were highly expressed in the studied strains. The overexpression of mexB and mexY was significantly more prevalent in the ICU wards (p = 0.033). Furthermore, there was a significant correlation between the expression of RND-type efflux pumps and the resistance to most anti-pseudomonal antibiotics.

Sofosbuvir/daclatasvir regimens for the treatment of COVID-19: an individual patient data meta-analysis.

BACKGROUND: The combination of sofosbuvir and daclatasvir has a well-established safety profile and improves clinical outcomes in HCV patients. In silico and in vitro studies suggest that sofosbuvir/daclatasvir may show antiviral activity against SARS-CoV-2. METHODS: Three clinical trials comparing sofosbuvir/daclatasvir-based regimens with a comparator in hospitalized COVID-19 patients were combined in a meta-analysis. The primary outcomes measured were clinical recovery within 14 days of randomization, time to clinical recovery and all-cause mortality. A two-step approach was used to analyse individual-level patient data. The individual trial statistics were pooled using the random-effects inverse-variance model. RESULTS: Our search identified eight studies of which three met the inclusion criteria (n = 176 patients); two studies were randomized and one was non-randomized. Baseline characteristics were similar across treatment arms. Clinical recovery within 14 days of randomization was higher in the sofosbuvir/daclatasvir arms compared with control arms [risk ratio = 1.34 (95% CI = 1.05-1.71), P = 0.020]. Sofosbuvir/daclatasvir improves time to clinical recovery [HR = 2.04 (95% CI = 1.25-3.32), P = 0.004]. The pooled risk of all-cause mortality was significantly lower in the sofosbuvir/daclatasvir arms compared with control arms [risk ratio = 0.31 (95% CI = 0.12-0.78), P = 0.013]. CONCLUSIONS: Available evidence suggests that sofosbuvir/daclatasvir improves survival and clinical recovery in patients with moderate to severe COVID-19. However, the sample size for analysis was relatively small, one of the trials was not randomized and the designs were not standardized. These results need to be confirmed in larger randomized controlled trials.