ABSTRACT
PURPOSE: Till date, only systemic corticosteroids have demonstrated definite mortality benefit in management of COVID 19 in various studies. Still certain questions regarding the appropriate dose, duration and timing of corticosteroids remain unanswered. For this reason, the study was planned to determine the efficacy and safety of the pulse dose methyl prednisolone in management of COVID 19 from the publicly available evidence. METHODS: PubMed, the Cochrane library, ClinicalTrials.gov and medRxiv were searched for articles reporting the use of pulse dose methyl prednisolone in COVID 19 from inception till 31st May, 2021. Odds ratios (ORs) were calculated for estimation of pooled effect by using random effect model and heterogeneity was checked by using I2 statistics. RESULTS: Twelve studies (11 observational and 1 RCT) were included in the systematic review. A total of 3110 patients from 9 studies were included in the meta-analysis. Though the use of pulse dose methyl prednisolone demonstrated statistically significant mortality benefit in comparison to usual care (OR=0.71, 95% CI: 0.51 to 0.97, [P=0.03]), (I2= 21%) with calculated Number needed to treat (NNT) of 23.5, there was no statistically significant difference between the use of pulse dose and low dose corticosteroid (OR=0.66, 95% CI: 0.44 to 1.01, [(P=0.05]), (I2= 25%) and the NNT is 23.5. Incidence of adverse events were similar across all the groups. The grade of evidence for primary outcome was of moderate certainty. CONCLUSION: This meta-analysis concurs with the previous reports regarding the use of corticosteroid in COVID 19 in comparison to usual care. However, for both the primary and secondary outcome, the study did not find any statistically significant difference between the use of pulse dose methyl prednisolone and low dose corticosteroid to treat COVID 19 patients.
Subject(s)
COVID-19 Drug Treatment , Methylprednisolone , Adrenal Cortex Hormones , Humans , Methylprednisolone/therapeutic useABSTRACT
COVID-19 pandemic has brought the vibrant and vivacious human life to a grinding halt. Only a safe and effective vaccine will bring this dicey situation back to normalcy. Researchers across the globe are at present working hard to find an effective vaccine for COVID-19. However, in search of an effective vaccine at the earliest possible time to combat the epidemic, we cannot afford to compromise on the safety of it. Therefore, monitoring the safety of vaccines is a top priority to safeguard the health of vaccine recipients and only a robust vaccine pharmacovigilance can ably do that in this crisis.
ABSTRACT
Though Convalescent plasma therapy (CPT) is being used for management of COVID-19, the evidence is still equivocal. So, we carried out this study to evaluate the currently available data to provide evidence about CPT in COVD-19 patients. RCTs and observational studies with sample size with more than 5 were included in the analysis. Out of 196 studies, 12 studies were selected for systematic review and meta-analysis was carried out for 6 studies having a control arm. For dichotomous values, risk ratio (RR) and 95% confidence interval was expressed. MAIN OUTCOMES: All-cause mortality, clinical improvement by day 7 and viral detection by day 7 were the defined outcome measures before starting of data extraction. RESULT: For 6 studies (2 RCTs and 4 observational studies) with 474 patients, the overall pooled RR for all-cause mortality was 0.61 (95%CI: 0.37 to 0.99. P= 0.04). Only RCTs and only observational studies for all-cause mortality showed pooled RR of 0.60 (95% CI: 0.33 to 1.10, P=0.10) and 0.48 (95% CI: 0.17 to 1.36, P= 0.17) respectively. There was risk of bias in the studies due to randomization process and confounding. Sensitivity analysis was carried out only for observational studies. The overall pooled RR for clinical improvement by day 7 and viral detection by day 7 were 1.12 (95%CI: 0.96 to 1.31, P=0.16) and 0.19 (95%CI: 0.09 to 0.60, P < 0.0001). CONCLUSION AND RELEVANCE: Though the review suggests modest utility of CPT in reducing all-cause mortality, improving clinical outcome, and early viral clearance, it should be interpreted cautiously.
Subject(s)
Betacoronavirus , Coronavirus Infections , Pandemics , Pneumonia, Viral , COVID-19 , Coronavirus Infections/therapy , Humans , Immunization, Passive , SARS-CoV-2 , COVID-19 SerotherapyABSTRACT
The current management of COVID-19 is mostly limited to general supportive care and symptomatic treatment. Ivermectin is a broad-spectrum anti-parasitic drug used widely for the treatment of onchocerciasis and lymphatic filariasis. Apart from its anti-parasitic effect it also exhibits antiviral activity against a number of viruses both in vitro and in vivo. Hence, we conducted this systematic review and meta-analysis to assess the currently available data on the therapeutic potential of ivermectin for the treatment of COVID-19 as add on therapy. A total of 629 patients were included in the 4 studies and all were COVID-19 RT-PCR positive. Among them, 397 patients received ivermectin along with usual therapy. The random effect model showed the overall pooled OR to be 0.53 (95%CI: 0.29 to0.96) for the primary outcome (all-cause mortality) which was statistically significant (P=0.04). Similarly, the random effect model revealed that adding ivermectin led to significant clinical improvement compared to usual therapy (OR=1.98, 95% CI: 1.11 to 3.53, P=0.02). However, this should be inferred cautiously as the quality of evidence is very low. Currently, many clinical trials are on-going, and definitive evidence for repurposing this drug for COVID-19 patients will emerge only in the future.