Therapeutics for Inpatients with COVID-19 (TICO)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2000

Inclusion Criteria

1.Age = 18 years;
2.Informed consent by the patient or the patient’s legally-authorized representative (LAR)*
3.SARS-CoV-2 infection, documented by PCR or other nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests will be maintained);
4.Duration of symptoms attributable to COVID-19 = 12 days per the responsible investigator;
5.Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.

*Continuing consent
For participants whose consent was initially obtained from a LAR, but who subsequently regain decision-making capacity while in hospital will be approached for consent for continuing participation, including continuance of data acquisition.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion Criteria

1.Prior receipt of any SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19 or any SARS-CoV-2 nMAb at any time prior to hospitalisation;
2.Not willing to abstain from participation in other COVID-19 treatment trials until after Day 5 (with the approval of study leadership, enrollment before or on Day 5 is permitted for trials comparing different approaches for implementing SOC interventions that are recommended in Appendix I);
3.In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol-specified assessments;
4.Expected inability to participate in study procedures;
5.Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through Month 18 of the study.
6.Men who are unwilling to abstain from sexual intercourse with women of child-bearing potential or who are unwilling to use barrier contraception through Month 18 of the study.

Prior to the initial futility assessment for an investigational agent, the following two additional exclusions (7 and 8) which define disease severity stratum 2 apply:

7.Presence at enrolment of any of the following:
a.stroke
b.meningitis
c.encephalitis
d.myelitis
e.myocardial infarction
f.myocarditis
g.pericarditis
h.symptomatic congestive heart failure (NYHA class III-IV)
i.arterial or deep venous thrombosis or pulmonary embolism

8. Current or imminent requirement for any of the following:
a.invasive mechanical ventilation
b.ECMO
c.mechanical circulatory support
d.vasopressor therapy
e.commencement of renal replacement therapy at this admission (i.e. not patients on chronic renal replacement therapy).

8. Women who are pregnant or breastfeeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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