Covid-19 Living Data

Trial NCT04452435
Publication ATTRACT - Tornling G, EClinicalMedicine (2021) (published paper)
Dates: 2020-07-21 to 2020-09-29
Funding: Mixed (Vicore Pharma; LifeArc)
Conflict of interest: Yes

Methods
	RCT Blinding: quadruple blinding
	Location : Multicenter / India Follow-up duration (days): 14
Inclusion criteria	Patients aged 19 to 69 years Hospitalised with SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) test <4 days before enrolment Signs of an acute respiratory infection Not requiring invasive or non-invasive mechanical ventilation on the day of randomisation C-reactive protein (CRP) value of >50 and <150 mg/L Written informed consent obtained prior to any trial-related procedure.
Exclusion criteria	Any previous experimental treatment for COVID-19 Need for mechanical invasive or non-invasive ventilation Concurrent respiratory disease such as chronic obstructive pulmonary disease, idiopathic pulmonary disease (IPF) and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days) prior to COVID-19 diagnosis Participation in any other interventional trial within 3 months prior to Visit 1 Any of the following findings at Visit 1: - Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1+2 antigen/antibody (HIV 1+2 Ag/Ab) - Positive pregnancy test (see Section 8.2.3) Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I Treatment with any of the medications listed below within 1 week prior to Visit 1: - Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. John’s Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbiturates) - Warfarin Pregnant or breast-feeding female subjects Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1 Male subjects not willing to use contraceptive methods as described in Section 5.3.1 Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
Interventions
	Treatment Compound 21 100 mg twice daily orally for 7 days
	Control Placebo
Participants
	Randomized participants : Compound 21=51 Placebo=55
	Characteristics of participants N= 106 Mean age : NR 80 males Severity : Mild: n=26 / Moderate: n=76 / Severe: n=0 Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Change from baseline in C-reactive protein (CRP) after treatment with C21 200 mg daily dose (100 mg b.i.d.) [ Time Frame: Treatment period of 7 days ]
	In the report Change in CRP from baseline to end-of-treatment
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing willing stated in the publication: Yes
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 article and all versions of the pre-print article, the study registry (dated 30 June, 2020), protocol, and statistical analysis plan were used in data extraction and risk of bias assessment. The target sample size specified in the registry and protocol was not achieved due to recruitment difficulties. There were no substantive differences between the trial registry, study protocol and statistical analysis plan and the pre-print article. The outcomes WHO score 7 and above, Adverse events and Serious adverse events were not pre-specified. On the 29th of July, 2021, this study was updated based on updated pre-print. On the 17th of November, the study was updated based on the published article.