Therapeutics for Inpatients with COVID-19 (TICO)

Phase 1

• Conditions: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2); MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-003278-37-GR
• Lead Sponsor: Regents of the University of Minnesota

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-05
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 5000

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.
*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. The consent form signed
by the LAR should reflect that such consent should be obtained.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2500

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 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 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).
Women who are pregnant or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified