Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients.
Nat Commun
; 13(1): 2583, 2022 05 11.
Article
in En
| MEDLINE
| ID: mdl-35546145
ABSTRACT
Data on convalescent plasma (CP) treatment in COVID-19 outpatients are scarce. We aimed to assess whether CP administered during the first week of symptoms reduced the disease progression or risk of hospitalization of outpatients. Two multicenter, double-blind randomized trials (NCT04621123, NCT04589949) were merged with data pooling starting when <20% of recruitment target was achieved. A Bayesian-adaptive individual patient data meta-analysis was implemented. Outpatients aged ≥50 years and symptomatic for ≤7days were included. The intervention consisted of 200-300mL of CP with a predefined minimum level of antibodies. Primary endpoints were a 5-point disease severity scale and a composite of hospitalization or death by 28 days. Amongst the 797 patients included, 390 received CP and 392 placebo; they had a median age of 58 years, 1 comorbidity, 5 days symptoms and 93% had negative IgG antibody-test. Seventy-four patients were hospitalized, 6 required mechanical ventilation and 3 died. The odds ratio (OR) of CP for improved disease severity scale was 0.936 (credible interval (CI) 0.667-1.311); OR for hospitalization or death was 0.919 (CI 0.592-1.416). CP effect on hospital admission or death was largest in patients with ≤5 days of symptoms (OR 0.658, 95%CI 0.394-1.085). CP did not decrease the time to full symptom resolution. TRIAL REGISTRATION Clinicaltrials.gov NCT04621123 and NCT04589949. REGISTRATION NCT04621123 and NCT04589949 on https//www. CLINICALTRIALS gov.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
COVID-19
Type of study:
Clinical_trials
/
Prognostic_studies
/
Risk_factors_studies
/
Systematic_reviews
Limits:
Humans
/
Middle aged
Language:
En
Journal:
Nat Commun
Journal subject:
BIOLOGIA
/
CIENCIA
Year:
2022
Type:
Article
Affiliation country:
Spain