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History of Changes for Study: NCT04374461
A Study of N-acetylcysteine in Patients With COVID-19 Infection
Latest version (submitted July 22, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 1, 2020 None (earliest Version on record)
2 May 5, 2020 Eligibility, Outcome Measures and Study Status
3 May 7, 2020 Eligibility and Study Status
4 May 20, 2020 Arms and Interventions and Study Status
5 May 28, 2020 Arms and Interventions and Study Status
6 July 1, 2020 Study Status
7 September 30, 2020 Study Design, Study Status, Eligibility and Arms and Interventions
8 October 29, 2020 Study Status
9 November 25, 2020 Study Status
10 March 8, 2021 Study Status and Arms and Interventions
11 July 21, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
12 July 22, 2022 Study Status
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Study NCT04374461
Submitted Date:  May 1, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: 20-168
Brief Title: A Study of N-acetylcysteine in Patients With COVID-19 Infection
Official Title: Phase II Study of N-acetylcysteine in Severe or Critically Ill Patients With Refractory COVID-19 Infection
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2020
Overall Status: Recruiting
Study Start: May 1, 2020
Primary Completion: May 2021 [Anticipated]
Study Completion: May 2021 [Anticipated]
First Submitted: May 1, 2020
First Submitted that
Met QC Criteria:
May 1, 2020
First Posted: May 5, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
May 1, 2020
Last Update Posted: May 5, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Memorial Sloan Kettering Cancer Center
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary:

The study researchers think that a medication called N-acetylcysteine can help fight the COVID-19 virus by boosting a type of cell in your immune system that attacks infections. By helping your immune system fight the virus, the researchers think that the infection will get better, which could allow the patient to be moved out of the critical care unit or go off a ventilator, or prevent them from moving into a critical care unit or going on a ventilator.

The US Food and Drug Administration (FDA) has approved N-acetylcysteine to treat the liver side effects resulting from an overdose of the anti-inflammatory medication Tylenol® (acetaminophen). N-acetylcysteine is also used to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease (COPD). This study is the first to test N-acetylcysteine in people with severe COVID-19 infections.

Detailed Description:
Open or close this module Conditions
Conditions: Covid-19
Keywords: N-acetylcysteine
20-168
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
This is a single-institution study that will be open at MSKCC's Manhattan campus. Patients will be enrolled into 2 separate arms.
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 86 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: mechanically ventilated &/or managed in a critical-care

Patients in both arms will receive N-acetylcysteine IV 6 g/day in addition to supportive and/or COVID-19 directed treatments at the discretion of the treating physician.

Patients will receive treatment for a maximum of 3 weeks or until one of the following:

Arm A:

  • Transfer out of the critical-care unit
  • Extubation
  • Toxicity
  • Death
Drug: N-acetylcysteine
Patients in both arms will receive N-acetylcysteine IV 6 g/day in addition to supportive and/or COVID-19 directed treatments at the discretion of the treating physician.
Experimental: non-mechanically ventilated, non-critical-care

Patients in both arms will receive N-acetylcysteine IV 6 g/day in addition to supportive and/or COVID-19 directed treatments at the discretion of the treating physician.

Patients will receive treatment for a maximum of 3 weeks or until one of the following:

Arm B:

  • Discharge from hospital
  • Admission to a critical-care unit
  • Intubation
  • Toxicity
  • Death
Drug: N-acetylcysteine
Patients in both arms will receive N-acetylcysteine IV 6 g/day in addition to supportive and/or COVID-19 directed treatments at the discretion of the treating physician.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. number of patient's that transfer out of critical care unit or extubation (Arm 1)
[ Time Frame: 1 year ]

2. number of patient's that are discharge from hospital
[ Time Frame: 1 year ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Documented COVID-19 infection (either performed on site or documented external report) 2. Age ≥ 18 3. Arm A:
    1. Admission to an intensive care unit at MSK (M-11 or M-18) and/or receiving mechanical ventilation
    2. Absolute lymphocyte count ≤ 1.0/mm3 4. Arm B:
    1. Requiring L by nasal cannula or higher to maintain SpO2 of 95%

Exclusion Criteria:

  • Arm B: requiring mechanical ventilation or admission to an intensive care unit at MSK (M11 or M18)
Open or close this module Contacts/Locations
Central Contact Person: Santosha Vardhana, MD, PhD
Telephone: 646-888-3285
Email: vardhans@mskcc.org
Central Contact Backup: Jedd Wolchok, MD, PhD
Telephone: 646-888-2395
Study Officials: Santosha Vardhana, MD, PhD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Locations: United States, New York
Memorial Sloan Kettering Cancer Center
[Recruiting]
New York, New York, United States, 10065
Contact:Contact: Santosha Vardhana, MD, PhD 646-888-3285
Contact:Contact: Jedd Wolchok, MD, PhD 646-888-2395
Open or close this module IPDSharing
Plan to Share IPD: Yes
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links: Description: Memorial Sloan Kettering Cancer Center
Available IPD/Information:

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