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SSRN; 2022.
Preprint in English | SSRN | ID: ppcovidwho-331858


Background: Waning of neutralizing titers and decline of protection shorter after the second dose of COVID-19 vaccines was observed, including China-made inactivated vaccines. Efficacy of a heterologous boosting using one dose recombinant SARS-CoV-2 fusion protein vaccine (V-01) in inactivated vaccine-primed population was studied, aimed to restore the immunity. Methods: A randomized, double-blind and placebo-controlled phase Ⅲ trial was conducted in healthy people aged 18 years or older in Pakistan and Malaysia. Each eligible participant received one dose of V-01 vaccine developed by Livzon Mabpharm Inc . or placebo 3-6 months after the 2-dose primary regimen, and was monitored for safety and efficacy. The primary endpoint was protection against confirmed symptomatic SARS-CoV-2 infection. Results: A total of 10,218 participants were randomly assigned to receive vaccine or placebo. Virus-neutralizing antibodies were assessed in 419 participants. A dramatical increase (11.3-fold;128.3 to 1452.8) of neutralizing titers was measured in V-01 group at 14 days after the booster. Over the two months surveillance, vaccine efficacy was 47.8% (95%CI: 22.6 to 64.7) according to the intention-to-treat principle. The most common adverse events were transient, mild-to-moderate pain at the injection site, fever, headache, and fatigue. Serious adverse events occurred almost equally in V-01 (0.12%) and placebo (0.16%) groups. Conclusion: The heterologous boosting with V-01 vaccine was safe, efficacious, and could elicit robust humoral immunity under the epidemic of the Omicron variant.

JAMA Intern Med ; 182(4): 426-435, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1704290


Importance: Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19. Evidence-based data to recommend either for or against the use of ivermectin are needed. Objective: To determine the efficacy of ivermectin in preventing progression to severe disease among high-risk patients with COVID-19. Design, Setting, and Participants: The Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients (I-TECH) study was an open-label randomized clinical trial conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and October 25, 2021. Within the first week of patients' symptom onset, the study enrolled patients 50 years and older with laboratory-confirmed COVID-19, comorbidities, and mild to moderate disease. Interventions: Patients were randomized in a 1:1 ratio to receive either oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care (n = 241) or standard of care alone (n = 249). The standard of care consisted of symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging. Main Outcomes and Measures: The primary outcome was the proportion of patients who progressed to severe disease, defined as the hypoxic stage requiring supplemental oxygen to maintain pulse oximetry oxygen saturation of 95% or higher. Secondary outcomes of the trial included the rates of mechanical ventilation, intensive care unit admission, 28-day in-hospital mortality, and adverse events. Results: Among 490 patients included in the primary analysis (mean [SD] age, 62.5 [8.7] years; 267 women [54.5%]), 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk [RR], 1.25; 95% CI, 0.87-1.80; P = .25). For all prespecified secondary outcomes, there were no significant differences between groups. Mechanical ventilation occurred in 4 (1.7%) vs 10 (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17), intensive care unit admission in 6 (2.4%) vs 8 (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79), and 28-day in-hospital death in 3 (1.2%) vs 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09). The most common adverse event reported was diarrhea (14 [5.8%] in the ivermectin group and 4 [1.6%] in the control group). Conclusions and Relevance: In this randomized clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment during early illness did not prevent progression to severe disease. The study findings do not support the use of ivermectin for patients with COVID-19. Trial Registration: Identifier: NCT04920942.

COVID-19 , Ivermectin , Adult , Disease Progression , Female , Hospital Mortality , Humans , Ivermectin/adverse effects , Ivermectin/therapeutic use , Middle Aged , SARS-CoV-2 , Treatment Outcome
Malays Fam Physician ; 15(1): 1, 2020.
Article in English | MEDLINE | ID: covidwho-61707