Trial NCT04425915
Publication COPLA-II trial - Bajpai M, BMJ Open (2022) (published paper)
Dates: 2020-06-14 to 2020-11-17
Funding: No specific funding (The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors. )
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Multicenter / India
Follow-up duration (days): 28
Inclusion criteria
  • Age 18 or above
  • informed consent
  • WHO Interim Guidance defined severe COVID-19 as following any of the two criteria out of five including ventilated patient within 24 hours, respiratory rate ≥30 beats/min, oxygen saturation in the resting state level less than 90% in resting state, Partial pressure of oxygen/ Fractional inspired oxygen ratio (PaO2)/(FiO2) ≤300 mm Hg, and lung infiltrates ≥50% within 24–48 hours.
Exclusion criteria
  • A history of allergy to plasma
  • pregnancy
  • multiorgan failure
  • HIV
  • viral hepatitis
  • cirrhosis
  • renal impairment on dialysis and Renal replacement therapy (RRT)
  • cancer
  • uncontrolled hypertension and diabetes
  • arrhythmias
  • unstable angina and haemodynamically unstable patients requiring vasopressors
  • expected life expectancy less than 24 hours.
Interventions
Treatment
Convalescent plasma
250 m/L intravenously, once a day for 2 days
Control
Standard care

Participants
Randomized
participants :
Convalescent plasma=200
Standard care=200
Characteristics of participants
N= 400
Mean age : NR
269 males
Severity : Mild: n=1 / Moderate: n=312 / Severe: n=86 Critical: n=1
Number of vaccinated participants: 0
Primary outcome
In the register
Time to clinical improvement (Clinical improvement: Reduction of two points in ordinal scale or live discharge from the intensive care unit, whichever is earlier) [ Time Frame: Day 28 ]
In the report
Time to clinical improvement, defined as a reduction in ordinal scale by two points or live discharge, whichever was earlier up to 28 days.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

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 published article, the trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary and secondary outcomes in the article reflect those in the registry. The trial (n = 400) achieved its target sample size (n = 400).