A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19

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Status and phase: Completed; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Other: Standard of Care; Drug: RESP301, a Nitric Oxide generating solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04460183

RESP301-002

Details and patient eligibility

About

The effect of RESP301 as an add on treatment to SOC will be evaluated for its efficacy in reducing rate of progression to a more severe level of COVID-19 and for safety, by comparison with SOC alone in hospitalized COVID-19 patients.

Full description

This is an open-label, randomized, multicenter, parallel group, concurrent, controlled study using a sequential adaptive design to evaluate the efficacy and safety of RESP301 plus SOC versus SOC alone in hospitalized patients with COVID-19 (World Health Organization [WHO] ordinal scale level 3 or 4).

Approximately 300 participants will be enrolled and randomized 2:1 to the Investigational arm or the Control arm. The study will be divided into the following periods: Screening period: (up to 2 days), Intervention (up to 10 days), follow-up (Day 14 and Day 28).

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participant has laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcriptase polymerase chain reaction (RT-PCR) or other approved clinical testing prior to randomization.
2. Participant is hospitalized in relation to COVID-19, requiring supplemental oxygen to maintain SpO2 at a safe level (WHO level 3 & 4).
3. Participant is capable of giving signed informed consent
4. Participant is male or female. All females of childbearing potential, including pregnant females, must consent to urine pregnancy testing at screening to be eligible for the study.

Exclusion criteria

1. Rapidly deteriorating or likely to require escalation to high flow oxygen, invasive or non-invasive ventilatory support within 24 hours according to Investigator's opinion.
2. Unable to safely receive a nebulized treatment for approximately 8 minutes according to Investigator's opinion.
3. Unable to receive or considered ineligible for invasive or non-invasive ventilatory support.
4. History of methemoglobinemia.
5. Presence of uncontrolled asthma, history of severe bronchospasm.
6. Presence of severe chronic respiratory disease and tracheostomy.
7. Suspected or confirmed untreated, active tuberculosis.
8. Severely immune-compromised participants in Investigator's opinion.
9. Recent active coronary artery disease or decompensated heart failure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Investigational arm

Experimental group

Description:

Participants will receive inhaled RESP301 administered using a nebulizer three times a day for up to 10 days in addition to the standard of care.

Treatment:

Drug: RESP301, a Nitric Oxide generating solution

Other: Standard of Care

Control arm

Active Comparator group

Description:

Participants will receive institutional SOC for the treatment of COVID-19

Treatment:

Other: Standard of Care