Publication PLACOVID - Sekine L, Eur Respir J (2021) (published paper)
Dates: 2020-07-15 to 2020-12-10
Funding: Public/non profit (Fundação de Amparo à Pesquisa do Estado de São Paulo, Instituto Cultural Floresta, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul)
Conflict of interest: No
Single center / Brazil |
Follow-up duration (days): 28
300 mL 2 IV infusions 48 hours apart
|Characteristics of participants|
Mean age : NR
Severity : Mild: n=1 / Moderate: n=39 / Severe: n=52 Critical: n=68
Number of vaccinated participants: NR
|In the register|
Clinical improvement [ Time Frame: 28 days ]
|In the report|
Proportion of patients with clinical improvement 28 days after enrolment.
Yes. In English
Data-sharing willing stated in the publication:
|Risk of bias
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
In addition to the published article, the prospective protocol and statistical analysis plan and retrospective registry were used in data extraction and assessment of risk of bias. There were no substantive differences in population, procedures, interventions or primary outcome and secondary outcomes between the registry and protocol and the published article. The primary outcome was changed after start of recruitment, but with only 8 patients recruited and with appropriate approval from the national and local ethics committees. Although the trial was retrospectively registered during its conduct, the protocol was prospective and the final version reports no other substantive changes to outcomes. The study achieved its target sample size.
This study was updated on November 11th, 2021 with data from contact with authors.