Covid-19 Living Data

Trial *
Publication Murugesan H , J Assoc Physicians India (2021) (published paper)
Dates: 2020-10-01 to 2020-12-30
Funding: Private (Pfizer)
Conflict of interest: *

Methods
	RCT Blinding: Unblinded
	Location : Single center / India Follow-up duration (days): 28
Inclusion criteria	Hospitalized adult patients in the age group of 18 - 65 years diagnosed positive for SARS-CoV2 infection by RT-PCR radiological imaging (Chest X-ray or CT scan) confirmed pneumonia with lower respiratory tract infection features indicating moderate pneumonia.
Exclusion criteria	Patients on mechanical ventilation at the time of admission known allergy to tofacitinib participants who are immunocompromised , with known immunodeficiencies, or taking potent immunosuppressive agents or any potent cytochrome P450 inhibitors within the past 30 days receiving any corticosteroid treatment for 14 consecutive days prior to screening of major adverse cardiovascular event (MACE) and/or recent (one year ) revascularization history of deep venous thrombosis (DVT) or pulmonary embolism (PE) pre-existent neurodegenerative disease severe hepatic or renal impairment severe anemia (hemoglobin <8 g/dl) history of any malignancy or lymphoproliferative disorders that requires active treatment.
Interventions
	Treatment Tofacitinib 10 mg orally twice a day for 14 days
	Control Standard care
Participants
	Randomized participants : Tofacitinib =50 Standard care=50
	Characteristics of participants N= 100 Mean age : NR 74 males Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: 0
Primary outcome
	In the register NR
	In the report Proportion of patients not requiring any form of mechanical ventilation or high flow oxygen or ECMO at day 7 or mortality.
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	Only the published article was used in data extraction and assessment of risk of bias. No registry, protocol or statistical analysis plan was available, so it was not possible to determine whether the population, procedures, intervention and outcomes were predefined. This was a pilot study with a convenience sample of 100 patients.