Therapeutics for Inpatients with COVID-19 (TICO)

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Age more than or equal to 18 years

2. Informed consent by the patient or the patientâ??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.)

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 the approval of study leadership, enrollment before or on Day 5 is permitted for

trials comparing different approaches for implementing SOC interventions

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 acknowledge the strong advice to abstain from sexual intercourse with

men or practice appropriate contraception through 18 months of the study.

6. Men who are unwilling to acknowledge the strong advice to abstain from sexual

intercourse with women of child-bearing potential or to use barrier contraception through

18 months 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 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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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