Parul Rewari, Cody Powers and Judith Kulich co-wrote this blog post with Kristyn Feldman.
As nations around the globe are hit hard by the novel coronavirus pandemic, many are asking the same question: What treatments or preventions are in the pipeline that may address COVID-19? Researchers the world over have launched numerous research, preclinical and clinical-stage programs in an effort to identify vaccines and treatments that can tackle the virus or to find treatments that mediate the downstream effects of the virus.
We looked at ongoing clinical trials to understand the scope of clinical stage programs. We based this analysis on trials registered via clinicaltrials.gov and other resources1 (and excluded observational studies and those evaluating supplements or traditional Chinese medicine). We chose to cast a wide net and understand the breadth of development, including the vast array of assets being tested in China. By the close of the third week in March, there were more than 120 phase I to III clinical trials for COVID-19, with new trials being announced daily (figure 1).
Figure 1: Total number of phase I through III clinical trials for COVID-19 by week.1
Of the 120-plus phase I through III trials, there were 48 unique assets (vaccines or drugs) being tested (figure 2), with 11 unique assets in phase III (figure 3). The four vaccine candidates currently under investigation are in phase I to II, with antivirals, monoclonal antibodies or other treatments comprising the late-stage pipeline.
Figure 2: Details about the 48 unique drugs and vaccines currently being tested against SARS-CoV-2 (mAb = monoclonal antibodies; other = immunosuppressants, immunomodulators and various other assets).1 Geography is the primary country where the trial is being conducted.
Figure 3: Phase III unique assets being tested for COVID-19. There were three phase III trials under investigation in the U.S., with eight additional assets being tested in China.1
Additionally, there were 60 to 70 assets in preclinical research stages, with many major pharmaceutical companies announcing potential assets.
Each week, we’ll update this dashboard and review the newest candidates and trial results. This week, results of three clinical studies made headlines:
COVID-19 Study Results From the Week of March 20, 2020
March 17, 2020
Molecule (Sponsor): Hydroxy-chloroquine (IHU in Marseille, France) 2
Phase: Phase II/III
Details: In France, a professor conducted a small study (24 patients) of the malaria drug hydroxychloroquine in 24 patients with novel coronavirus infection:
-Of those who received the medicine, only 25% tested positive for the virus after six days
-Of those who didn't receive it, 90% tested positive after that time frame
There are more than six additional clinical trials in phase II to IV currently examining hydroxychloroquine
March 18, 2020
Molecule (Sponsor): Kaletra [lopinavir/ ritonavir] (AbbVie) 3,4
Phase: Phase II
Details: Top-line failure as researchers observed no benefit in severely ill patients hospitalized with COVID-19 when the HIV drug was added to standard of care:
-Standard care is comprised of (as necessary): supplemental oxygen, noninvasive and invasive ventilation, antibiotic agents, vasopressor support, renal-replacement therapy and extracorporeal membrane oxygenation (ECMO)
March 18, 2020
Molecule (Sponsor): Avigan [favipiravir] (Fujifilm Toyama Chemical/Hisun) 5,6
Phase: Phase II
Details: Preliminary results of the "Clinical Study on Favipiravir's Safety and Effectiveness to COVID-19 Patients" led by the Third People's Hospital showed that favipiravir alleviated the pneumonia symptom of COVID-19 patients with high tolerance and few adverse reactions, potentially through a mechanism that can quickly eliminate the coronaviruses from their bodies.
Later, results of clinical studies conducted in China suggested that Fujifilm's Avigan (favipiravir) may be effective at treating patients with COVID-19:
-Studies found that favipiravir, compared to Kaletra, substantially shortened the time to viral clearance (roughly four days vs. 11 days, respectively)
-Also, 91% of patients on favipiravir experienced improvement in chest computed tomography scans (compared to 62% on Kaletra)
Some reports state that favipiravir was approved by Chinese authorities, while studies continue in Japan and elsewhere.7,8
Check back each week for an updated view of the clinical development landscape and advancements in the search for safe and effective tools to fight the COVID-19 pandemic.
- ZS analysis of Adis, Citeline-Pharmaprojects, clinicaltrials.gov and Pharmcube data