Parul Rewari, Cody Powers, Judith Kulich and Amit Pangasa co-wrote this blog post with Kristyn Feldman.
The global COVID-19 pandemic continues to dominate headlines, including near constant updates from the pharma industry and academic clinical researchers the world over. Last week, we looked at the clinical-stage programs aimed to address the novel coronavirus. This week, we have expanded our analysis to include a wider range of clinical programs, including phase IV studies, and additional sources of data regarding this quickly evolving landscape.
By the close of the fourth week in March, there were more than 180 trials for COVID-19 listed on clinicaltrials.gov, over 60 more than last week (figure 1).1
Of the clinical stage trials listed in our expanded set of sources,2 we identified more than 100 unique assets (vaccines or treatments) being tested in phase I to phase IV (figure 2). This is almost double the number of assets from the same time last week. Considering only phase I to III trials, we found 34 additional trials this week. While this is partially due to expanding our sources of data to include unique assets from TrialTrove, many are new trials, with more initiating daily across the globe.
Figure 1: Total number of clinical trials, by phase, for COVID-19 by week.1
Of the six vaccine candidates currently under investigation, one phase I trial was added this week, four are in phase I to II, and one is in phase IV. Antivirals, monoclonal antibodies, cell-based therapies and other treatments make up the remainder of the late-stage pipeline.
Figure 2: Details about the unique drugs and vaccines currently being tested against SARS-CoV-2 (mAb = monoclonal antibodies; other = immunosuppressants, immunomodulators and various other assets).2 Geography is the primary country where the trial is being conducted.
Over the past week, a few key milestones made headlines:
COVID-19 Study Results and Milestones From March 23-30, 2020
March 30, 2020
Molecule (Sponsor): Hydroxychloroquine (University of Minnesota and many others)
Phase: Phase III and others
The FDA issued an emergency authorization for chloroquine and hydroxychloroquine in hospitalized patients with COVID-193
- The drugs can be distributed and prescribed through the Strategic National Stockpile
- Critics of these products, including the CDC website, note that the use in COVID-19 patients is “based upon limited in-vitro and anecdotal data”; interpretations of the clinical data from China and France do not provide enough evidence to support the conclusion that these drugs help patients. The study from China was small and open-label, with little to no benefit compared to control. The data from France was from a small, non-randomized, uncontrolled study. 4,5,6
March 25, 2020
Molecule (Sponsor): Remdesivir (Gilead Sciences)
Phase: Phase III
Gilead asks the FDA to rescind orphan status for remdesivir7
- Gilead was seeking orphan status for remdesivir in treating COVID-19, citing the hope to “expedite approval of the drug”
- The request drew criticism, as some viewed the request as inappropriate under the Orphan Drug Act8
March 24, 2020
Molecule (Sponsor): Danoprevir (Ganovo, Ascletis Pharma)
Phase: Small-sample clinical (phase IV)
Danoprevir (HCV protease inhibitor) tested in treatment-naive and experienced COVID-19 patients9
- Moderate COVID-19 patients were treated with four to 12 days of danoprevir combined with ritonavir
- All 11 were discharged from the hospital after meeting China National Standards, including improved respiratory symptoms and two negative SARS-CoV-2 tests10
March 23, 2020
Molecule (Sponsor): Actemra (tocilizumab, Ascletis Pharma)
Phase: Phase III
FDA gives Genentech the green light to test Actemra in a phase III trial for hospitalized patients with severe COVID-19 pneumonia11
- The trial aims to evaluate the safety and efficacy of Actemra (added to standard of care) in patients hospitalized with severe COVID-19 pneumonia
- While there are several other independent trials looking at Actemra, this trial is unique as it is well-controlled and was rapidly expedited by the FDA
Check back as we periodically provide an updated view of the clinical development landscape and advancements in the search for safe and effective tools to fight the COVID-19 pandemic.
For more ZS insights on the impact of COVID-19, visit zs.com/COVID19.
- ZS analysis of clinicaltrials.gov data
- ZS analysis of Adis, Citeline-Pharmaprojects, clinicaltrials.gov, Trialtrove and PharmCube data