Discovery of effective treatment for COVID-19 Infection

In the race to identify a treatment for the COVID-19 viral infection, we searched United States Trial Registry, www.clinicaltrials.gov and medical research literature. Our search on the term COVID resulted in 1995 studies. After removing vaccine and biologics; and restricting to small molecules, we noted there were 245 individual medicines in clinical trials of various research designs. However amongst all of the different types of studies, that have been completed recently and now published in peer reviewed journals, of note are two medicines, chloroquine and remdesevir.

New England Journal of Medicine (NEJM) is considered to be a medical journal of repute for publishing latest quality research in the field of medicine. This journal recently presented results of two clinical studies, one on Chloroquine (anti-malarial) and the other on Remdesevir (anti-viral).

The study on the medicine chloroquine was not as robust as that of Remdesevir since it did not have a comparative treatment arm and also it was not randomised (chance assignment of treatment between different treatment options in the study), rather this was observational in nature, and the results published failed to provide us a clear answer on its benefit for use in COVID-19 infection.

However the results published on Remdesevir, were from robust clinical trial design, which is called a randomised controlled trial (RCT). This trial showed that Remedesivir intravenous (IV – administration of medicine through veins), was superior to placebo (a dummy medicine treatment arm) in shortening the time of recovery in adult patients hospitalized Covid-19 having evidence of lower respiratory infection.

In this study 1063 patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The main treatment measure was the time to recovery from COVID-19 infection, which was defined by either discharge from the hospital or hospitalization for infection control purposes only.

Remdesevir showed shortened time to recovery compared to the placebo arm and based on positive results seen in this trial, data and safety monitoring board recommended early unblinding (uncovering the identity of medicine or placebo that was originally hidden from study participants and trial related staff), so that all patients can receive this medicine.

Preliminary results from the 1059 patients (538 assigned to Remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P<0.001).

The KaplanMeier estimates of mortality by 14 days were 7.1% with Remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). This has resulted in the U.S. Food and Drug Administration to issue an emergency use authorization for the investigational antiviral drug Remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.  

Serious adverse events were reported for 114 of the 541 patients in the Remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%).

Therefore we should be looking forward for more results from the large number of studies, that are underway to share the data, our interest is on results from robust randomised clinical trials, as these will provide us better understanding of the benefits and risks posed by the different medicines that are being researched.

Research Progress on COVID treatments as of June 8th 2020

Terms and Synonyms Searched :

Region wise medical research breakdown :

Reference:

Geleris J, et. al. Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19. N Engl J Med. 2020 May 7;. doi: 10.1056/NEJMoa2012410. [Epub ahead of print] PubMed PMID: 32379955; PubMed Central PMCID: PMC7224609.

Beigel JH, et. al, Remdesivir for the Treatment of Covid-19 – Preliminary Report. N Engl J Med. 2020 May 22;. doi: 10.1056/NEJMoa2007764. [Epub ahead of print] PubMed PMID: 32445440; PubMed Central PMCID: PMC7262788.

Source: https://ClinicalTrials.gov