Covid-19 Living Data

Trial IRCT20210614051574N5
Publication Haghighi S, SSRN (2021) (preprint)
Dates: 2021-06-01 to 2021-09-30
Funding: Mixed (Shahid Beheshti University of Medical Sciences. Sobhan Oncology Company provided thalidomide tablets )
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Single center / Iran Follow-up duration (days): 14
Inclusion criteria	Age more than 18 years old up to 65 years old positive PCR test oxygen saturation between 90-94% at the beginning of hospital admission chest CT-scan compatible with COVID-19 beginning of COVID-19 symptoms less than five days ago.
Exclusion criteria	Patients who needed mechanical ventilation at the beginning of randomization patients with cardiac (history of Ischemic heart disease and heart failure) hepatic (Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) more than five times upper limit) or renal dysfunction (Glomerular filtration rate less than 30 ml/min/1.73m2 ) obese patients with body mass index (BMI) more than 30 kg/m2 women who were pregnant or were on breastfeeding women who planned to be pregnant in the next one month patients who had received Thalidomide for any cause in one month before the randomization.
Interventions
	Treatment Thalidomide 100 mg orally daily for 14 days
	Control Standard care
Participants
	Randomized participants : Thalidomide=25 Standard care=25
	Characteristics of participants N= 50 Mean age : NR 34 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register 1) Complete clinical recovery time; 2) Mortality rate
	In the report 1) Duration of increment patient’s oxygen saturation to more than 94% from below this level 2) Duration of in-hospital admission.
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	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. The registry is labelled as prospectively registered on 13 September 2021 with an expected recruitment start date of 22 September 2021 and no updates, yet it also states that recruitment is completed and the recruitment dates reported in the article are June to September 2021. Neither protocol nor statistical analysis plan was available. There are some discrepancies between the registry and the article in inclusion and exclusion criteria. The trial is described as a randomized in the article, but as not randomized in the registry. The intervention and control treatments differed between the registry and the article: in the registry Thalidomide was to be compared with placebo, each along with “other routine treatments for pneumonia caused by COVID-19, such as antibiotics and fluid therapy”; in the article Thalidomide with Dexamethasone and Remdesivir was compared with Dexamethasone and Remdesivir alone. The primary outcomes in the article (time to O2 saturation 94%, duration of hospital stay) do not reflect the primary outcomes in the registry (time to complete recovery, mortality rate). The study (n = 50) did not achieve its target sample size (n = 100).