Safety and Feasibility of Umbilical Cord Mesenchymal Stem Cells in Patients with COVID-19 Pneumonia: A Pilot Study (preprint)

Background: We aim to explore the safety and feasibility of umbilical cord mesenchymal stem cells (UC-MSCs) transplantation in severe and critically severe type Coronavirus disease 2019 (COVID-19) patients.Methods: In addition to normal therapy, we performed four times transplantation of UC-MSCs in 16 severe and critically severe type COVID-19 patients. We observed adverse events from enrollment to D28. We evaluated the oxygenation index, inflammatory biomarkers, chest imaging, lymphocyte subsets count et al on the 7th day (D7±1 day), the 14th day (D14±1 day) and the 28th day (D28±3 days).Results: There were no infusion-related or allergic reactions. The oxygenation index was improved after transplantation. The mortality of enrolled patients was 6.25%. The level of cytokines estimated was varied in normal range, the chest imaging was improved, the lymphocyte count and lymphocyte subsets count were recovered after transplantation.Conclusions: Intravenous transplantation of UC-MSCs was safe and feasible for treatment in patients with COVID-19 pneumonia.Trial registration: Clinical Trial, NCT04269525. Registered 7 February 2020. https://clinicaltrials.gov/ct2/show/NCT04269525

Favipiravir versus Arbidol for COVID-19: A Randomized Clinical Trial (preprint)

Background No clinically proven effective antiviral strategy exists for the epidemic Coronavirus Disease 2019 (COVID-19). Methods We conducted a prospective, randomized, controlled, open-label multicenter trial involving adult patients with COVID-19. Patients were randomly assigned in a 1:1 ratio to receive conventional therapy plus Umifenovir (Arbidol) (200mg*3/day) or Favipiravir (1600mg*2/first day followed by 600mg*2/day) for 10 days. The primary outcome was clinical recovery rate of Day 7. Latency to relief for pyrexia and cough, the rate of auxiliary oxygen therapy (AOT) or noninvasive mechanical ventilation (NMV) were the secondary outcomes. Safety data were collected for 17 days. Results 240 enrolled COVID-19 patients underwent randomization; 120 patients were assigned to receive Favipiravir (116 assessed), and 120 to receive Arbidol (120 assessed). Clinical recovery rate of Day 7 does not significantly differ between Favipiravir group (71/116) and Arbidol group (62/120) (P=0.1396, difference of recovery rate: 0.0954; 95% CI: -0.0305 to 0.2213). Favipiravir led to shorter latencies to relief for both pyrexia (difference: 1.70 days, P<0.0001) and cough (difference: 1.75 days, P<0.0001). No difference was observed of AOT or NMV rate (both P>0.05). The most frequently observed Favipiravir-associated adverse event was raised serum uric acid (16/116, OR: 5.52, P=0.0014). Conclusions Among patients with COVID-19, Favipiravir, compared to Arbidol, did not significantly improve the clinically recovery rate at Day 7. Favipiravir significantly improved the latency to relief for pyrexia and cough. Adverse effects caused Favipiravir are mild and manageable. This trial is registered with Chictr.org.cn (ChiCTR2000030254).