Anti-spike Antibody Status in Pre-vaccinated Healthy Participants and Rheumatoid Arthritis Patients During the Third Wave of COVID-19.

Introduction Anti-spike severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies produced after infection with the coronavirus disease of 2019 (COVID-19) will offer protection and prevent re-infection for a few months. Seroprevalence studies measuring the SARS­CoV-2 immunoglobulin G (IgG) levels will be helpful to know the herd immunity level that prevents community transmission. Very few studies have addressed the antibody titer among healthy participants and rheumatoid arthritis (RA) patients. The present study was conducted to determine the anti-spike SARS-CoV-2 antibody (Ab) status before COVID-19 vaccination in healthy participants and RA patients. Methodology A cross-sectional study was conducted at a tertiary care hospital to estimate the serum anti-spike antibody levels against COVID-19 among the pre-vaccinated healthy participants and patients with RA during the third wave of COVID-19. After receiving written informed consent, participants were recruited as per the inclusion and exclusion criteria. Demographic details, co-morbid status, and medication details were collected. Five milliliters of blood samples were collected, and anti-spike antibodies were estimated. The SARS-CoV-2 Ab positivity rate was expressed in percentage and was correlated with gender and age groups. Ab-positive participants were classified into three categories based on the neutralizing antibody titers (NAT). Results A total of 58 participants (49 healthy volunteers and nine RA patients) were recruited. Out of 58 participants, 40 were males, nine were females among healthy participants, and one male and eight females in the RA group were enrolled. Among the RA patients, one participant was found to have the chronic obstructive pulmonary disease (COPD), and two participants with hypothyroidism. Antibody positivity was found to be 83.6% among the healthy volunteers and 100% in the RA patients. About 48% had NAT between 50 and 90%. There was no significant difference for age and gender-specific positivity for SARS-CoV-2 neutralizing antibodies and neutralizing antibody titers among healthy participants. Conclusion Our study showed 84% positivity for anti-spike SARS-CoV-2 antibodies around the third wave (between November 2021 and February 2022). The majority had high neutralizing antibody titers. The probable reason for the SARS-CoV-2 antibody positivity before vaccination was either asymptomatic infection or herd immunity.

Efficacy and Safety of Anti-SARS-CoV-2 Monoclonal Antibodies: An Updated Review.

Monoclonal antibodies (mAbs) had received emergency use authorization for mild-to-moderate coronavirus disease 2019 (COVID-19) or for prophylaxis against COVID-19, including casirivimab plus imdevimab (C+I), bamlanivimab plus etesevimab (B+E), tixagevimab plus cilgavimab (T+CG), and sotrovimab (S) and bebtelovimab (BEB). This systematic review was done to assess the efficacy and safety of the same. PubMed, Embase, Scopus, medRxiv, bioRxiv, and FDA fact sheets were searched for the studies published between January 2021 and May 2022, and appropriate search terms related to the mentioned mAbs were used for data collection. Review included original research including randomized clinical trials and observational studies published or preprints. Studies included in the review had compared with placebo or standard of care or no treatment or mAbs with each other and also of various doses. Data extraction was done and reviewed the same for both efficacy and safety. Total of 20 studies were included in this review. The rate of hospitalization within 30 days showed ∼2% in comparison to ∼7% with placebo. Significant reduction in viral load was more observed with combination mAbs. Combination therapy showed faster virological cure against the Gamma variant. With C + I as postexposure prophylaxis (PEP), 29.0% of asymptomatic participants developed symptomatic COVID-19. Pre-exposure prophylaxis with T+CG reduced the incidence of infection by 77%. Infusion-related reaction was the most common adverse event (AE). The neutralizing mAbs reduced hospitalization in mild-to-moderate patients with infusion-related reactions as common AE. The response was better in the seronegative patients. Most of these studies were conducted in unvaccinated individuals and against Alpha, Gamma, and Delta variants.

Adverse events following remdesivir administration in moderately ill COVID-19 patients - A retrospective analysis.

Introduction: Remdesivir, an antiviral drug, received an emergency use authorization for treating coronavirus disease 2019 (COVID-19) patients. Though many studies have reported the safety aspects of this antiviral agent, most of them were observed in severely ill COVID-19 patients, making very less data available in the moderately ill patients. The present study was conducted with an objective of finding the adverse events (AEs) associated with remdesivir in moderately ill COVID-19 patients. Methodology: A retrospective observational study was conducted by collecting data of demographic details and details of remdesivir, laboratory investigations, and AEs from the patient medical records from May to July 2021 and analyzed by using the appropriate statistics. Results: Out of the 160 COVID-19 patients, 32 were moderately ill (males: 29, females: 03) and were treated with remdesivir along with steroids and low molecular weight heparin (LMW) heparin. The average number of administered remdesivir doses was 4, with a loading dose of 200 mg and a maintenance dose of 100 mg. A total of 41 AEs were observed out of which 17 were adverse drug reactions (ADRs) (a significant increase in the alanine transaminase (ALT) [P < 0.001]) and 23 AEs (a significant rise in random blood sugars, RBS [one of the AEs] [P = 0.007]). The AEs were more commonly seen in the hypertensive patients. An increased oxygen requirement was a major serious AE observed in four patients. Conclusion: Remdesivir caused a significant increase in the liver enzymes. Increased blood sugar levels were the most common AE and increased oxygen requirement was the major serious AE observed.

Efficacy and safety of Molnupiravir in COVID-19 patients: a systematic review.

BACKGROUND: Molnupiravir is an oral antiviral drug that received Emergency Use Authorization in three countries for the treatment of mild COVID-19. The aim of this systematic review was to find out the safety and efficacy of Molnupiravir in SARS-COV-2 infections. METHODS: The electronic databases such as PubMed, MedRxiv, BioRxiv, FDA, ClinicalTrials.Gov, ctri.nic.in and Google Scholar were searched for articles from January 2021 to March 2022 using the keywords such as "Molnupiravir", "COVID-19", "Oral antiviral pill", "MK-4482", "EIDD-280", "Efficacy" and "Safety". Details of published, unpublished with interim reports and ongoing studies of Molnupiravir in COVID-19 were retrieved, and a systematic review was performed. RESULTS: A total of 6 articles and 18 ongoing trials data were collected. Out of these, data from 4 published and 2 unpublished with interim reports were extracted. After review of these studies, it was observed that the daily dose of 1600 mg Molnupiravir for 5 days was safe and tolerable with nausea, diarrhea and headache as the common adverse effects. The results also showed significant decrease in time to viral clearance with 800 mg twice daily in mild patients and reduction in the risk of hospitalization or death by 50% in non-hospitalized COVID-19 patients. CONCLUSION: Evidence from clinical studies showed that Molnupiravir caused significant reduction in the risk of hospitalization or death in high-risk mild COVID-19 patients. Molnupiravir was also found to be well tolerated and safe without any major adverse events on short-term use. For confirmative use of this drug in mild-to-moderate COVID-19 disease, further studies are required in vaccinated COVID-19 patients and against emerging variants.

Ivermectin in COVID-19 Management: What is the Current Evidence?

Ivermectin (IVM), an approved anthelminthic drug, has been reported to have antiviral, antibacterial, and anticancer activities. Antiviral activity is due to the inhibition of nuclear cargo importin (IMP) protein. The anti-SARS CoV-2 activity through in vitro study was first reported by an Australian team. Later, many studies were conducted, and most of the study results were available as non-peer-reviewed preprints. In this narrative review, literature on the clinical studies conducted with ivermectin from published articles, preprints, and unpublished evidence was collected until 13th June 2021. They are discussed based on the severity of COVID-19 disease. Out of the 23 peer-reviewed published articles, 13 studies were randomized controlled trials. The remaining were either prospective interventional, prospective observational, retrospective cohort, cross-sectional, or case series type of studies; additionally, there were 10 randomized controlled trials available as preprints. In most studies, ivermectin was used in combination with doxycycline, azithromycin, or other drugs. Some studies suggested that a higher dose or increased duration of ivermectin usage was required to achieve favorable effects. In this review, articles on the prophylactic role of ivermectin in COVID-19 are also discussed - wherein the results are more promising. Despite accumulating evidence suggesting the possible use of ivermectin, the final call to incorporate ivermectin in the management of COVID-19 is still inconclusive.