Trial NCT04405310
Publication Fernandez-Sanchez V, Research Square (2022) (preprint)
Dates: 2020-05-20 to 2020-10-10
Funding: Public/non profit (CEMEVAV (Centro Medico Naval, Naval Medical Center))
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Multicenter / Mexico
Follow-up duration (days): 21
Inclusion criteria
  • Adults 18 to 70 years of age
  • diagnosis of COVID-19 confirmed by RT-PCR
  • Hscore ≥169 points
  • severe acute hypoxemia with SpO2 <90% on room air and PaO2 /FiO2 <300 mmHg
  • Meeting imaging criteria for SARS-CoV-2 stage II and III pneumonia (plain chest CT scan or plain chest X-ray)
  • requirement for supplemental oxygen either via face mask plus reservoir bag, high-flow nasal prongs or advanced airway management, and invasive mechanical ventilatory support
  • C reactive protein (CRP) value increased by 3.5 the baseline or greater than 18 mg/dL
  • Stage II was defined as evidence of lower airway disease, either by clinical assessment or imaging, and oxygen saturation (SpO2) ≥94%. Stage III was defined as a respiratory rate >30 breaths per minute, SpO2 <94%, ratio between the arterial partial pressure of oxygen and the fraction of inspired oxygen (PaO2 /FiO2) <300 mmHg, or pulmonary infiltrates >50%.
Exclusion criteria
  • Patient has no interest in participating in the trial
  • bilateral pulmonary infiltrate related to heart failure or other cause of water overload
  • Virus positive respiratory viral panel other than COVID-19
  • History of allergy to plasma, sodium citrate, or methylene blue
  • Patients with a history of autoimmune diseases or selective IgA insufficiency
  • Those patients who are participating in other protocols.
Interventions
Treatment
Convalescent plasma
300 mL/day intravenously, on day one and day three
Control
Placebo
300 mL of 20% albumin in Hartman's solution intravenously on day one and day three

Participants
Randomized
participants :
Placebo=11
Convalescent plasma=32
Characteristics of participants
N= 43
Mean age : NR
0 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=15
Number of vaccinated participants: 0
Primary outcome
In the register
Death [ Time Frame: 15 days ] any cause
In the report
Survival at 15 and 21 days
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Yes
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment “In addition to the pre-print article, the prospective study registry was used in data extraction and risk of bias assessment. The protocol and statistical analysis plan were not available. No outcome is defined as the primary outcome in the article and the mortality outcome reported (to 21 days) has a different timepoint from the primary outcome in the registry (mortality at day 15). The pilot study (n=42) did not achieve the target sample size specified in the trial registry (n=80)."