RESULTS
dysgeusia, anosmia, diarrhea
ADVERSE EVENT, ADVERSE EVENT, CORONAVIRUS, RESOLUTION, SEVERE ACUTE RESPIRATORY SYNDROME
During the study, 127 patients were assessed for eligibility, and 123 were randomly assigned to the study arms: 63 in the nelfinavir group and 60 in the control group (Flowchart of the study patients. Analysis sets: intention-to-treat (ITT) population, all randomly assigned patients; safety analysis set (SAS) and full analysis set (FAS), all randomly assigned patients who received the study treatment at least once. SOC, standard-of-care.Patients’ baseline characteristics are summarized in Baseline characteristics of the study patientsSD, standard deviation; LAMP, loop-mediated isothermal amplification.Patient who discontinued.Including 11 (nelfinavir group) and 6 (control group) tested for both PCR and antigen test.Viral load was measured using only quantitative RT-PCR.Nextclade and corresponding Pangolin lineage were as follows: 20B: B.1.1, B.1.1.214, B.1.1.284, and R.1; 20C: B.1.346; 20I (Alpha): B.1.1.7; 21A (Delta): B.1.617.2 and AY.29.After initiating the study, 57 patients in each group had two consecutive negative RT-PCR results. The median time to viral clearance was 8.0 (95% confidence interval [CI], 7.0 to 12.0) days in the nelfinavir group and 8.0 (95% CI, 7.0 to 10.0) days in the control group (Time to clearance of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The median time to viral clearance from randomization is 8.0 (95% confidence interval [CI], 7.0 to 12.0) days in the nelfinavir group and 8.0 (95% CI, 7.0 to 10.0) days in the control group (Subgroup analysis of the time to clearance of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from symptom onset in patients treated within 3 days of symptom onset. The median time to viral clearance is 13.0 (95% confidence interval [CI], 10.0 to 17.0) days in the nelfinavir group and 13.0 (95% CI, 10.0 to 14.0) days in the control group (When comparing only the viral load on day 1 (Distributions of area under the curve (AUC) and half-life of viral load. Individual values of (A) AUC and (B) half-life of viral load for patients in the nelfinavir and control groups with box plots that show the quantiles. AUC was calculated as the summation of the product of the measured viral load and the measurement interval. Half-life was estimated using only measurements above the detection limit after attaining the peak of viral load.During the study, COVID-19-related symptoms resolved in most patients within 28 days in both groups, but dysgeusia and anosmia persisted in 15 to 30% of the patients (Resolution of symptoms in patients with mild COVID-19CI, confidence interval.Per no. of patients with the symptom.log-rank test.During the study, 47 (74.6%) patients in the nelfinavir group and 20 (33.3%) in the control group experienced at least one adverse event (Adverse events occurring in at least two patients in any groupThe concomitant drugs used during the study period (days 1 to 28) are listed in Table S2. More patients took antidiarrheals in the nelfinavir group than in the control group (33.3% [21/63] versus 6.7% [4/60]), given the increased frequency of diarrhea as an adverse event of nelfinavir. The numbers of patients who took certain types of drugs, including steroids, antipyretics, antitussives, and antivirals, that may affect symptoms, morbidity, severity, or time for viral clearance were similar between the two groups.