Therapeutics for Inpatients with COVID-19 (TICO)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

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 a 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

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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 500

Exclusion Criteria

1.Prior receipt of
•Any SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19 or
•SARS-CoV-2 nMAb at any time prior to hospitalization

2.Not willing to abstain from participation in other COVID-19 treatment trials until after Day 5 (with thie 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 a)i))(1)(a)(i)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 acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 18 month of the study

6.Men who are unwilling acknowledge the strong advice to to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 18 month of the study

Prior to the initial futility assessment for an investigational agent, the follwoing two additional exclusions (7 and 8) which define disease severity stratum 2 apply:
7.Presence at enrollment of any of the following:
a.stroke
b.meningitis
c.encephalitis
d.myelitis
e.myocardial infarction
f.myocarditis
g.pericarditis
h.symptomatic CHF (NYHA class III-IV)
i.arterial or deep venous thrombosis or pulmonary embolism

8.Current 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).

Exclusions that may be appropriate for an investigational agent studied are referenced in the relevant appendix (H) for the investigational agent. The contraindications for use of components of SOC are outlined in Appendix I and in the PIM

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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