Data extraction and sources
One author (DJ) extracted data using a pre-standardized form. Quality
control was performed by re-extracting data from 15% of the included
trial registers. Information on the trial ID, scientific title, date of
registration, recruitment status, patient population and funding sources
were extracted from the WHO-ICTRP database. Information on the country
where the trials were planned to be conducted was extracted primarily
from the WHO-ICTRP database and completed using the trial register data
when appropriate.
The trial’s register was accessed and provided addition information to
characterize the RCTs according to:
- Number of participants planned to be recruited;
- Age and sex of the participants planned to be recruited;
- Intervention and comparison treatments, including doses and
administration schedules;
- Treatment duration;
- Efficacy/effectiveness outcomes defined as primary endpoints;
- Safety outcomes, i.e., adverse events;
- Timeframe for the assessment of the efficacy/effectiveness and safety
outcomes;
- Mode data collection of the safety outcomes.
The efficacy/effectiveness outcomes were classified as clinical (e.g.,
improvement or recovery of respiratory symptoms) or surrogate outcomes
(e.g., viral load, biomarkers, etc.). The mode of data collection of the
adverse events was classified as “systematic assessment ” when
specific ascertaining methods to detect the occurrence of adverse events
were described by the use of checklists, questionnaires, or laboratory
tests at regular intervals, and as “non-systematic
assessment ” when the detection methods relied on the spontaneous
report of adverse events by clinicians or participants15.