Trial IRCT20200408046987N1
Publication Niaee MS, Asian Pac J Trop Med (2021) (published paper)
Dates: 2020-06-01 to 2020-07-15
Funding: Mixed (Qazvin University of Medical Sciences and Science (publication); Chistasazan Notash Fartak Company Limited (registry))
Conflict of interest: *

Methods
RCT
Blinding:
Location : Multicenter / Iran
Follow-up duration (days): 45
Inclusion criteria
  • Age >18 years

  • Signed the informed consent

  • Clinical symptoms of suggestive of COVID-19 pneumonia: cough (with or without sputum), fever, pleuritic chest pain or dyspnea

  • Mild to severe COVID-19 disease confirmed by chest computed tomography (CT) scan findings compatible with COVID-19 or positive real-time reverse transcription polymerase chain reaction (RT-PCR).
Exclusion criteria
  • Presence of severe immunosuppression (e.g., use of immune-suppressants and HIV positive)

  • Pregnant women

  • Allergic reaction to the intervention
  • Chronic kidney disease

  • Malignancy
  • Severe COVID-19 patients and indications that the patients were unable and/or unlikely to comprehend and/or follow the protocol.
Interventions
Treatment
Control
Placebo/NA

Standard care/NA

Participants
Randomized
participants :
Placebo/NA=30
Standard care/NA=30
Characteristics of participants
N= 60
Mean age : NR
30 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
Chest image (CT scan) at hospital clearance;
Hospitalization time;
CBC and CRP
In the report
The primary endpoint of this trial was all-cause of mortality or clinical recovery. Clinical recovery was defined as normal temperature, respiratory rate, and oxygen saturation (>94%) without oxygen therapy sustained for 24 h.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:
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/pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. There were some differences between the registry and the published/pre-print article in terms of inclusion criteria, number of treatment arms, and outcomes (registry: chest CT scan, length of hospitalization, complete blood count, C-reactive protein; article: clinical recovery defined as normal fever, respiratory rate, and oxygen saturation >94% without oxygen therapy sustained for 24h). Mortality was not listed as an outcome in the registry. The study achieved its pre-stated sample size. The overall follow-up of the study is unclear.