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Gas
Nitric Oxide for COVID-19 (NoCovid Trial)
Phase 2
Waitlist Available
Led By Lorenzo Berra, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Spontaneous breathing with or without hypoxia of any degree. Gas exchange and ventilation maybe assisted by any continuous airway pressure (CPAP), or any system of Non Invasive Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) ≤ 10 cmH2O
Hospital admission with at least one of the following: fever ≥ 36.6 °C from axillary site, or ≥ 37.2°C from oral site, or ≥ 37.6°C from tympanic or rectal site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
NoCovid Trial Summary
This trial will test whether inhaled nitric oxide therapy can prevent the progression of COVID-19 in patients with mild to moderate symptoms.
Who is the study for?
This trial is for people with confirmed COVID-19 showing mild to moderate symptoms like fever, cough, or breathing difficulties but not severe enough to require high-flow oxygen or intubation. They must be newly hospitalized and not part of another study. Those with tracheostomies, on certain oxygen therapies, or with other health issues that the doctor thinks could interfere are excluded.Check my eligibility
What is being tested?
The trial is testing if inhaling Nitric Oxide (NO) gas can stop the worsening of COVID-19 in patients. NO has shown promise against similar viruses in the past. Participants will breathe in NO through a mask or tube to see if it helps improve their lung function and prevents severe disease progression.See study design
What are the potential side effects?
Inhaling Nitric Oxide may cause side effects such as headache, dizziness, nausea, or increased bleeding risk. It might also lead to low blood pressure when standing up too quickly after sitting or lying down.
NoCovid Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can breathe on my own, even if I need some assistance.
Select...
I was admitted to the hospital with a fever measured from underarm, mouth, ear, or rectum.
NoCovid Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation
Secondary outcome measures
Mortality
Time to clinical recovery
Other outcome measures
Negative conversion of COVID-19 RT-PCR from upper respiratory tract
NoCovid Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Nitric Oxide inhalationExperimental Treatment1 Intervention
Nitric Oxide will be delivered through a non invasive CPAP system (with minimal pressure support to decrease discomfort due to the facial mask) or through a non-rebreathing mask system.
Group II: Nitric Oxide Inhalation (Non-Randomized)Experimental Treatment1 Intervention
All subjects part of this arm will receive nitric oxide gas either as an inpatient or outpatient. Nitric Oxide will be delivered through a non invasive CPAP system (with minimal pressure support to decrease discomfort due to the facial mask) or through a non-rebreathing mask system. Patients in this arm will not be randomized, so that all patients receive the study medication.
Group III: ControlActive Control1 Intervention
Patients assigned to the control group will not receive any gas therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitric Oxide
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,285 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,583 Previous Clinical Trials
2,279,974 Total Patients Enrolled
Lorenzo Berra, MDPrincipal InvestigatorMassachusetts General Hospital
16 Previous Clinical Trials
764 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was hospitalized for reasons other than COVID-19.You have tested positive for COVID-19 through a lab test or have antibodies for the virus.I was admitted to the hospital with a fever measured from underarm, mouth, ear, or rectum.I am currently using a high flow nasal cannula for breathing support.I have been in the hospital with COVID-19 for over 72 hours.I can breathe on my own, even if I need some assistance.I need oxygen at home for my lung condition.I have a cough.Your breathing rate is 24 breaths per minute or higher.You are currently taking part in another research study.I have a tracheostomy.You do not want full life support measures in place, such as "do not resuscitate" (DNR), "do not intubate" (DNI), or "comfort measures only" (CMO).I was previously on a ventilator for COVID-19.
Research Study Groups:
This trial has the following groups:- Group 1: Nitric Oxide inhalation
- Group 2: Control
- Group 3: Nitric Oxide Inhalation (Non-Randomized)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available positions for new participants in this experiment?
"This coronavirus study is not currently enrolling new patients. The listing was first posted on March 21st, 2020 and was updated as recently as October 31st, 2022. 24 different Nitric Oxide Inhalation (Non-Randomized) trials are still looking for participants."
Answered by AI
How many individuals are being monitored in this experiment?
"Unfortunately, this particular study has already wrapped up recruitment. The trial was first posted on March 21st, 2020 and the most recent update occurred on October 31st, 2022. However, there are plenty of other research studies currently underway that might be a better fit - 1314 clinical trials related to coronavirus infections and 24 for Nitric Oxide Inhalation (Non-Randomized) are still actively recruiting patients."
Answered by AI
Has the FDA cleared Nitric Oxide Inhalation (Non-Randomized) for use?
"While there is some evidence to support its safety, the lack of data on efficacy gives Nitric Oxide Inhalation (Non-Randomized) a score of 2."
Answered by AI
Are there other examples of clinical trials using Nitric Oxide Inhalation (Non-Randomized)?
"There are currently 24 ongoing trials for Nitric Oxide Inhalation (Non-Randomized), 9 of which have reached Phase 3. The great majority of these clinical tests are being conducted in Anchorage, Alaska; however, there are 116 total locations running these trials."
Answered by AI
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