COVID-19Phase 3INFECT-19NCT04455243
Inflammatory Regulation Effect of NAC on COVID-19 Treatment
A Phase 3 study testing N-Acetyl cysteine in people with COVID-19, run by Dr. Tariq Alhawassi.
Trial summary
Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- N-Acetyl cysteine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,180 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 30 Aug 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult above 18 years of age
- Admitted to the hospital With confirmed COVID-19 by RT-PCR test
- On oxygen supplement
Who cannot join
- Active use of NAC
- Known NAC allergy
- In the opinion of the treating team, progression of death is imminent and inevitable within the next 24 hour, irrespective of provision treatment
- All patients enrolled in any other investigational drug studies in COVID-19.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Double Blinded Randomized Placebo Controlled Multi Central Clinical Trial on Inflammatory Regulation Effect of NAC on COVID-19
Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19.
- Conditions
- COVID-19
- Being tested
- N-Acetyl cysteine, Placebo
- Keywords
- NAC
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetyl cysteineDrug
Also called NAC
150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)
PlaceboDrug
Matching placebo administered in the same schedule and volume as NAC
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Drug: N-Acetyl cysteine |
| Control group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recovery
Day of recovery is defined as the first day on which of the following three categories from The Ordinal Scale on Covid-19 Clinical Improvement
- Not-Hospitalized, No limitation on activity.
- Not Hospitalized, with limitation on activity.
- Hospitalized, Not requiring supplemental Oxygen
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Tariq Alhawassi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Tariq Alhawassi, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455243
- Sponsor's protocol ID
- E-20-4934
- Acronym
- INFECT-19
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD data will be shared. However, the exact sharing plans on what or when is not yet decided.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Double Blinded Randomized Placebo Controlled Multi Central Clinical Trial on Inflammatory Regulation Effect of NAC on COVID-19
- ClinicalTrials.gov ID
- NCT04455243
- Acronym / sponsor ID
- INFECT-19 / E-20-4934
- Conditions
- COVID-19
- Keywords
- NAC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,180 participants (estimated)
- Lead sponsor
- Dr. Tariq AlhawassiUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study times to evaluate the efficacy of N-Acetylcysteine therapy in the management of adult admitted patients with COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: N-Acetyl cysteine |
| Control group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult above 18 years of age
- Admitted to the hospital With confirmed COVID-19 by RT-PCR test
- On oxygen supplement
Key exclusion criteria (4 listed)
- Active use of NAC
- Known NAC allergy
- In the opinion of the treating team, progression of death is imminent and inevitable within the next 24 hour, irrespective of provision treatment
- All patients enrolled in any other investigational drug studies in COVID-19.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetyl cysteineAlso: NAC150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS) | Drug | Intervention group |
| PlaceboMatching placebo administered in the same schedule and volume as NAC | Drug | Control group |
Primary outcome
Time to Recovery
Time frame: 28 days
Day of recovery is defined as the first day on which of the following three categories from The Ordinal Scale on Covid-19 Clinical Improvement 1. Not-Hospitalized, No limitation on activity. 2. Not Hospitalized, with limitation on activity. 3. Hospitalized, Not requiring supplemental Oxygen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Individual participant dataSharing planned: Undecided. IPD data will be shared. However, the exact sharing plans on what or when is not yet decided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-Acetyl cysteine in people with COVID-19, run by Dr. Tariq Alhawassi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baian Alabdulbaqi, MD (+966114670011, balabdulbaqi@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Recovery (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.