Trial NCT04885530
Publication ACTIV 6 - Naggie S, medRxiv (2022) (preprint)
Dates: 2021-08-10 to 2022-02-12
Funding: Mixed (National Center for Advancing Translational Sciences (NCATS); Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority; GSK provided the product used in the study.)
Conflict of interest: No

Methods
RCT
Blinding: triple blinding
Location : Multicenter / USA
Follow-up duration (days): 28
Inclusion criteria
  • Outpatients with mild-to-moderate Covid-19
  • confirmed SARS-CoV-2 infection ≤10 days - confirmed positive polymerase chain reaction (PCR) or antigen test for SARS-CoV-2 infection, including home-based testing
  • aged ≥30 years
  • experiencing ≥2 Covid-19 symptoms for ≤7 days from enrollment. Symptoms included the following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, nasal symptoms, and new loss of sense of taste or smell.
Exclusion criteria
  • Hospitalization
  • known allergy or contraindication including prohibited concomitant medications
  • study drug use within 14 days of enrollment
  • pregnancy, breastfeeding
  • milk protein hypersensitivity
  • use within <30 days of inhaled or systemic corticosteroids.
Interventions
Treatment
Fluticasone
200 mcg by inhalation once a day for 14 days
Control
Placebo

Participants
Randomized
participants :
Fluticasone=715
Placebo=692
Characteristics of participants
N= 1407
Mean age : NR
470 males
Severity : Mild: n= 1277/ Asymptomatic: n=0
Number of vaccinated participants: 435
Primary outcome
In the register
Number of hospitalizations as measured by patient reports. [ Time Frame: Up to 28 days ]; Number of deaths as measured by patient reports [ Time Frame: Up to 28 days ]; Number of symptoms as measured by patient reports [ Time Frame: Up to 28 days ]
In the report
Time to recovery, defined as the third of 3 consecutive days without symptoms.
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 trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol no statistical analysis plan was available. There is no change from the trial registration in the intervention and control treatments. The primary outcome in the article (time to recovery) differed from the three primary outcomes available in the platform study in the in the registry (number of hospitalizations, deaths and symptoms). A substantial proportion (9.2%) of those randomized were not included in follow up and analysis because they did not receive the study interventions due to the study’s decentralized design and reliance on home delivery. Nevertheless, the trial (n = 1277) achieved its target sample size (n = 1200).