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A trial of arbidol hydrochloride in adults with COVID-19
Jingya Zhao1,2, Jinnong Zhang3, Yang Jin4
1Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China.
Insights
Arbidol tablets significantly improved negative conversion rates for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and accelerated recovery in COVID-19 patients. No serious adverse events were observed during treatment.
Area of Science:
- Virology
- Infectious Diseases
- Clinical Pharmacology
Background:
- No effective treatments for COVID-19 currently exist.
- The efficacy of arbidol for COVID-19 treatment is debated.
- This study aimed to assess arbidol's effectiveness and safety in COVID-19 patients.
Purpose of the Study:
- To evaluate the efficacy and safety of arbidol tablets in treating COVID-19.
- To determine if arbidol improves viral clearance and clinical outcomes.
Main Methods:
- A prospective, open-label, multicenter trial.
- Adult patients with confirmed SARS-CoV-2 infection were randomized to standard-of-care (SOC) or SOC plus arbidol.
- The primary endpoint was SARS-CoV-2 negative conversion within one week.
Main Results:
- Arbidol significantly increased negative conversion rates (70.3% vs. 42.4%).
- Patients on arbidol showed faster clinical recovery, fever resolution, and shorter hospitalization.
- Arbidol use led to quicker normalization of blood lymphocytes, with minimal adverse events like elevated transaminase.
Conclusions:
- Arbidol combined with SOC significantly enhances SARS-CoV-2 negative conversion and accelerates COVID-19 recovery.
- No significant serious adverse events were noted with arbidol treatment.
Background:
To date, there is no effective medicine to treat coronavirus disease 2019 (COVID-19), and the antiviral efficacy of arbidol in the treatment for COVID-19 remained equivocal and controversial. The purpose of this study was to evaluate the efficacy and safety of arbidol tablets in the treatment of COVID-19.
Methods:
This was a prospective, open-label, controlled and multicenter investigator-initiated trial involving adult patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Patients were stratified 1:2 to either standard-of-care (SOC) or SOC plus arbidol tablets (oral administration of 200 mg per time, three times a day for 14 days). The primary endpoint was negative conversion of SARS-CoV-2 within the first week. The rates and 95% confidential intervals were calculated for each variable.
Results:
A total of 99 patients with laboratory-confirmed SARS-CoV-2 infection were enrolled; 66 were assigned to the SOC plus arbidol tablets group, and 33 to the SOC group. The negative conversion rate of SARS-CoV-2 within the first week in patients receiving arbidol tablets was significantly higher than that of the SOC group (70.3% [45/64] vs . 42.4% [14/33]; difference of conversion rate 27.9%; 95% confidence interval [CI], 7.7%-48.1%; P = 0.008). Compared to those in the SOC group, patients receiving arbidol tablets had a shorter duration of clinical recovery (median 7.0 days vs . 12.0 days; hazard ratio [HR]: 1.877, 95% CI: 1.151-3.060, P = 0.006), symptom of fever (median 3.0 days vs . 12.0 days; HR: 18.990, 95% CI: 5.350-67.410, P < 0.001), as well as hospitalization (median 12.5 days vs . 20.0 days; P < 0.001). Moreover, the addition of arbidol tablets to SOC led to more rapid normalization of declined blood lymphocytes (median 10.0 days vs . 14.5 days; P > 0.05). The most common adverse event in the arbidol tablets group was the elevation of transaminase (5/200, 2.5%), and no one withdrew from the study due to adverse events or disease progression.
Conclusions:
SOC plus arbidol tablets significantly increase the negative conversion rate of SARS-CoV-2 within the first week and accelerate the recovery of COVID-19 patients. During the treatment with arbidol tablets, we find no significant serious adverse events.
Trial Registration:
Chinese Clinical Trial Registry, NCT04260594, www.clinicaltrials.gov/ct2/show/NCT04260594?term=NCT04260594&draw=2&rank=1.
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