Trial NCT04518410
Publication ACTIV-2 - Taiwo BO, Top Antivir Med (2022) (unpublished results)
Dates: 2021-04-01 to 2021-08-30
Funding: Not reported/unclear
Conflict of interest: *

Methods
RCT
Blinding: triple blinding
Location : Multicenter / USA
Follow-up duration (days): 28
Inclusion criteria
  • Participants with confirmed SAR-CoV-2 infection
Exclusion criteria NR
Interventions
Treatment
SAB185
3.84 units/kg IV infusion single dose
Control
Placebo

Participants
Randomized
participants :
SAB185=107
Placebo=106
Characteristics of participants
N= 213
Mean age : NR
0 males
Severity : Mild: n= */ Asymptomatic: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
1) COVID-19 symptom duration (Phase 2) [ Time Frame: Up to Day 28 ] Duration defined as the number of days from start of investigational agent to the first of two consecutive days when any symptoms scored as moderate or severe as study entry (pre-treatment) are scored as mild or absent; and any symptoms scored as mild or absent at study entry are scored as absent, AND any symptoms scored as mile or absent at study entry (pre-treatment) are scored as absent. Targeted symptoms are: Feeling feverish; cough, shortness of breath or difficulty breathing; sore throat; body pain or muscle pain/aches; fatigue (low energy); headache, chills, nasal obstruction or congestion (stuffy nose); nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)
2) Quantification of SARS-CoV-2 RNA (Phase 2) [ Time Frame: Day 3 ] Measured as quantification (3) Quantification of SARS-CoV-2 RNA (Phase 2) [ Time Frame: Day 7 ] Measured as quantification (4) Quantification of SARS-CoV-2 RNA (Phase 2) [ Time Frame: Day 14 ] Measured as quantification (5)Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 2) [ Time Frame: Thru Day 28 ] Cumulative incidence of death due to any cause or hospitalization due to any cause (Phase 3) [ Time Frame: Thru Day 28 ] Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19
In the report
1) Proportion of participants with SARS-CoV-2 RNA < lower limit of quantification (LLoQ) in nasopharyngeal(NP) swab
2) Time to improvement in targeted symptoms for 2 consecutive days after Day 0
3) Safety through Day 28
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
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
*
General comment The abstract and study registry were used in data extraction. No review specific outcomes were extractable. This study is part of the the ACTIV-2 platform trial.