International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response improves clinical outcomes among patients with COVID-19.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NEAT ID Foundation

Criteria

Inclusion Criteria:

1. Hospitalized for COVID-19

2. ≥18 years of age

3. SARS-CoV-2 infection, documented by:

1. nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR

2. 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 is maintained in Appendix E. Appendix E. Non-NAT Tests Deemed with Equivalent Specificity to NAT by the Protocol Team).

4. Hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy

5. Symptoms or signs of acute COVID-19, defined as one or more of the following:

1. cough

2. reported or documented body temperature of 100.4 degrees Fahrenheit or greater

3. shortness of breath

4. chest pain

5. infiltrates on chest imaging (x-ray, CT scan, lung ultrasound)

Exclusion Criteria:

1. Onset of COVID-19 symptom fulfilling inclusion criterion #5 >14 days prior to randomization

2. Hospitalized with hypoxemia (as defined in inclusion #4) for >72 hours prior to randomization (the 72-hour window for randomization begins when the patient first meets the hypoxemia inclusion criteria after hospital admission)

3. Pregnancy

4. Breastfeeding

5. Prisoners

6. End-stage renal disease (ESRD) on dialysis

7. Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life.

8. The treating clinician expects inability to participate in study procedures or participation would not be in the best interests of the patient

9. Known allergy/hypersensitivity to IMP or its excipients