Trial NCT04365127
Publication Ghandehari S, SSRN (2020) (preprint)
Dates: 2020-04-27 to 2020-08-20
Funding: Private (The Institut Biochimique SA (IBSA, Lugano, Switzerland))
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Single center / USA Follow-up duration (days): 15 | |
Inclusion criteria |
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Exclusion criteria |
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Interventions | |
Treatment
Progesterone 100 mg subcutaneously twice a day for up to 5 days. |
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Control
Standard care | |
Participants | |
Randomized participants : Progesterone=20 Standard care=22 | |
Characteristics of participants N= 42 Mean age : NR 40 males Severity : Mild: n=6 / Moderate: n=31 / Severe: n=3 Critical: n=0 | |
Primary outcome | |
In the register Change in clinical status of subjects at Day 7 based on the following 7-point ordinal scale: a. Death; b. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); c. Hospitalized, on high flow oxy | |
In the report Change in clinical status of participants from baseline to Day 7 | |
Documents avalaible |
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 |
Some concerns |
General comment |
In addition to the pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither study protocol not statistical analysis plan was available. The study achieved its pre-stated sample size. There were no substantive differences in population or procedures between the pre-print article and the trial registry. The time-point for the primary outcome was changed in the registry after completion of recruitment and follow up. Adverse events and serious adverse events were not pre-specified in the registry. The study only reported a list of non-serious Grade 3 and 4 adverse events which could not be extracted for Total adverse events as it does not account for Grades 1 and 2.
According to the Procedures section of the report, "control patients with significant clinical deterioration, requiring higher supplemental oxygen through high flow devices or mechanical ventilation at any point during the study, or those at Day 7 without clinical improvement were permitted to cross over to receive progesterone therapy." Furthermore, change in clinical status of subjects on day 15 was registered as an outcome but not reported as such in the paper/report. Only death at day 15 was able to be determined from the Results text of the paper/report. |