Title:Comparison of Efficacy of Remdesivir with Supportive Care Alone in the
Treatment of Critically Sick Adult and Child COVID-19 Patients: A Randomized
Clinical Trial
Volume: 21
Issue: 1
Author(s): Ahmad Hormati, Sajjad Ahmadpour, Mohammad Reza Ghadir, Seyed Yaser Foroghi Ghomi, Javad Tafaroji, Zahra Movahedi, Seyed Kamal Eshagh Hossaini, Morteza Khoshgoftar and Mina Gheitani*
Affiliation:
- Department of Internal Medicine, Qom University of Medical Sciences,
Qom, Iran
Keywords:
Infectious disease, COVID-19, mechanical ventilation, treatment, remdesivir, PCR test.
Abstract:
Background: Seeking new specific and effective drugs against Coronavirus Diseases-2019
(COVID-19) is of great importance. This study describes the efficacy of remdesivir with supportive care
alone in the treatment of critically sick adult and child COVID-19 patients.
Methods: This study was a one-blind placebo-controlled, randomized clinical trial in adults (aged≥18 years)
and children (aged≤12 years) in Iran. Patients were included if they had positive PCR test for SARS-CoV-2
infection, O2 saturation ≤88%, and compatible symptoms. All participants received standard care following
national treatment guidelines. The treatment group received remdesivir (200 mg IV on day 1 and followed
by 100 mg in single daily infusions). The control group received standard care and an identical volume of
placebo infusions (Water for injection) for 5 days. For pediatric patients, the intervention group received
remdesivir (5mg/kg on the first day and then 5.2 mg/kg on days 2 to 5). Discharge from the hospital within
10 days of first treatment is considered as the primary endpoint of the study. Admission in the intensive care
unit (ICU) is considered as original secondary endpoint of the study.
Results: 141 patients were enrolled and randomly assigned to two group (adults; 54 patients in the intervention
group vs. 52 patients in the control group, and children; 17 patients in the intervention group vs. 18
patients in the control group). The mean time from the first symptoms until the referral to the hospital in
adult patients was 5.61 ± 2.67 day and 4.80±1.48 day for intervention and control groups, respectively. The
mean time from the first symptoms until death was reported to be significant and was longer for intervention
group than the control group (24.83 ± 11.25 vs. 10.50 ± 2.42 day; p value=0. 012). For children who received
remdesivir, the mean time between admission until death was reported to be significant, as the finding highlighted
a longer time duration for the intervention group (13.55 ± 0.72 vs. 10.66 ± 0.57 day; p value=0.
Mechanicalanical ventilation was used in 17 patients (100%) and 18 patients (100%) in the intervention and
control groups, respectively (p value=0.853).
Conclusion: Among patients with critical COVID-19, those randomized to a 5-day treatment of remdesivir
did have a statistically significant difference in clinical status compared with the control group of both adults
and children.