S-Nitrosylation Therapy of COVID-19
- Registration Number
- NCT04528771
- Lead Sponsor
- James Reynolds
- Brief Summary
The primary objective of this study is to provide expanded access of S-nitrosylation therapy for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.
- Detailed Description
Randomized controlled trial for safety of a 6-hour escalating dose of S-nitrosylation therapy or placebo to ventilated patients. This will be a single-site study conducted within the UH-CMC medical ICU designated COVID-19 quarantine areas.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Nitrogen gas 12 patients in the placebo arm will receive nitrogen gas (six-hour treatment). SNO SNO 12 patients in the S-nitrosylation arm will receive SNO (six-hour treatment with a sequential increasing dose regimen of 20 ppm x 2 hr, 40 ppm x 2 hr, 80 ppm x 2 hr).
- Primary Outcome Measures
Name Time Method Progression to use of ECMO 30 days Use of ECMO required.
Treatment Emergent Adverse Events 30 days Adverse events related to SNO therapy.
Frequency of Intubation 30 days Number of intubations required.
- Secondary Outcome Measures
Name Time Method Discontinuation of Oxygen Therapy 30 days Proportion of patients alive and with discontinued oxygen supportive therapy at day 30
All-Cause Mortality 30, 60 days All-cause mortality
Clinical Status 30 days Proportion of patients in each stage at maximum severity on the 9-point clinical status assessment ordinal scale.
Clinical status will be assessed using the WHO 9-point ordinal scale as follows:
0. Uninfected - no clinical or virological evidence of infection
1. Ambulatory - no limitation of activities
2. Ambulatory - Limitation of activities
3. Hospitalized, mild disease - no oxygen therapy
4. Hospitalized, mild disease - oxygen by mask or nasal prongs
5. Hospitalized, severe disease - non-invasive ventilation or high-flow oxygen
6. Hospitalized, severe disease - intubation and mechanical ventilation
7. Hospitalized, severe disease - ventilation + additional organ support (pressors, RRT, ECMO)
8. DeadTime to Clinical Status Improvement 30 days Number of days required to see a greater than or equal to 2 point improvement on the WHO 9-point clinical status assessment ordinal scale.
Clinical status will be assessed using the WHO 9-point ordinal scale as follows:
0. Uninfected - no clinical or virological evidence of infection
1. Ambulatory - no limitation of activities
2. Ambulatory - Limitation of activities
3. Hospitalized, mild disease - no oxygen therapy
4. Hospitalized, mild disease - oxygen by mask or nasal prongs
5. Hospitalized, severe disease - non-invasive ventilation or high-flow oxygen
6. Hospitalized, severe disease - intubation and mechanical ventilation
7. Hospitalized, severe disease - ventilation + additional organ support (pressors, RRT, ECMO)
8. DeadRespiratory Clinical Status 30 days Respiratory clinical status assessed by a 7-point respiratory status ordinal scale that captures oxygen requirement, ventilator support or death.
7-Point Respiratory Severity Scale Range: 1-7 Higher values = worse
1. Not receiving oxygen supplementation; AND room air oxygen saturation ≥ 95%
2. Supplemental oxygen ≤ 2 liters/min; OR room air oxygen saturation ≤ 94%
3. Supplemental nasal oxygen \>2 and \<= 5 liters/min
4. Supplemental nasal oxygen \>5 liters/min
5. HFNC or NIV with FiO2 \> 50%
6. Intubation or ECMO
7. DeathDuration of Hospitalization 30 days Duration of total hospitalization days as measured by total hospitalization, ventilator and ICU days
Time to Discontinuation of Oxygen Therapy 30 days Number of days required to discontinue oxygen supportive therapy
Trial Locations
- Locations (1)
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States