With the number of COVID-19 cases and deaths increasing with each passing day, the need for a therapeutic or a vaccine for the pandemic intensifies. Currently, 21 ongoing COVID-19 clinical trials have reported interim results, out of which 16 showed positive early results, says GlobalData, a leading data and analytics company.
These clinical trials are in phases, with 69% of them in early stage trials (Phase I to Phase II). Majority of them are investigating different drugs, either alone or combination treatments, with one using a secondary intervention. The four multinational clinical trials that are planning to enroll the most subjects are investigating remdesivir, sarilumab and bevacizumab. One of the drugs that recently had positive clinical trials results is remdesivir.”
Scotty Chung-Siu, Senior Analyst of MPH at GlobalData
The majority of these trials started in 2020, just after the news broke about the virus. These trials have an estimated end date between April 2020 and March 2021 that will provide more data on the efficacy of the treatments for COVID-19.
The results from a Phase III ongoing trial by Gilead evaluating the safety and efficacy of remdesivir in patients with severe COVID-19 were announced on 29 April 2020. Remdesivir demonstrated similar clinical improvement in patients receiving a 10-day treatment to those receiving a five-day treatment.
In addition, more than half of the patients were discharged by Day 14 in both treatment groups while also achieving clinical recovery. Lastly, the drug candidate was well tolerated in both subject groups. A second clinical trial using remdesivir reported preliminary results on 29 April 2020. The trial reported a 31% faster recovery time over those who received placebo. In addition, the recovery time was 11 days for patients who were treated with remdesivir, compared to 15 days for placebo.”
Not all of the drugs had positive results. Hydroxychloroquine, an immunosuppressive drug often touted by US President Donald Trump, has recently failed to meet endpoints and saw adverse events in a retrospective study. Moreover, the patients treated with hydroxychloroquine had a higher mortality rate. Nonetheless, the number of clinical trials investigating hydroxychloroquine or chloroquine as a primary or secondary drug continues to expand.
Chung-Siu concludes: “There are two clinical trials that showed early negative results for efficacy and safety. One is a Phase III clinical trial evaluating the efficacy and safety of darunavir and cobicistat in the treatment of COVID-19 pneumonia. The other study is a Phase II clinical trial to evaluate the safety and efficacy of chloroquine for the treatment of hospitalized subjects with severe acute respiratory syndrome. Both interventional trials have the same expected end date of 31 August 2020.
“While many of the current COVID-19 clinical trials show promising early results, conclusions can only be drawn once the final data are reported. With 597 planned clinical trials, there will be more data to draw insights in the coming months and possibly a key drug candidate treatment for COVID-19 will emerge.”