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Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Hospitalized Patients (NICOVID)

Primary Purpose

SARS-COV2

Status

Completed

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour

Placebo of NICOTINE Transdermal patch

About this trial

This is an interventional treatment trial for SARS-COV2 focused on measuring SARS-COV2, COVID19, NICOTINE, transdermal patch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
Patients hospitalized for less than 72 hours
Non-smoking and non-vaping patients (for former smokers or former vapers: abstinent for at least 12 months)
Documented diagnosis of COVID19
Lung disease suggestive of COVID-19 on chest scanner or need for oxygen therapy
Obtaining, informed and signed consent
Affiliated to a social security scheme or beneficiary of such a scheme (except AME)

Exclusion Criteria:

WHO 10-point Clinical Progression Scale score > 5 (patient on non-invasive or mechanical ventilation, patient in need of high-flow oxygen therapy)
Indication of transfer to intensive care unit (oxygen therapy> 8 L / min ; out or not carried out due to LATA)
Current treatment with nicotine replacement therapy, bupropion or varenicline in the last 30 days
Known addiction problem to alcohol or other substances
Contraindication for nicotine patches:
- pregnant or breastfeeding woman
- lack of effective contraception for women of childbearing age
- Generalized skin pathologies that may interfere with the use of a transdermal patch
- stroke or myocardial infarction or acute coronary syndrome for less than 3 months
- allergy to nicotine or to one of the excipients of the transdermal patch
- Uncontrolled high blood pressure
- Unstable or worsening angina
- Severe cardiac arrhythmia (defined by wearing an automatic implantable defibrillator)
- Known obliterating peripheral arterial disease
- Known severe heart failure with an ejection fraction <30%)
- Known severe renal (ClCr <30 ml / min) or hepatic (Child C) impairment
- Known pheochromocytoma
- Known uncontrolled hyperthyroidism
- Esophagitis due to gastroesophageal reflux disease or an active peptic ulcer
Patient included in another interventional trial evaluating a health product
Patient under guardianship or curatorship
Patient deprived of liberty by judicial or administrative decision

Sites / Locations

Hospital Pitié-Salpêtrière - AP-HP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NICOTINE transdermal patch

Placebo of NICOTINE transdermal patch

Arm Description

NICOTINE 7 mg / 24h, transdermal patch

Placebo of nicotine patch

Outcomes

Primary Outcome Measures

The unfavorable outcome on Day 14

Defined by scores higher than 5 on the World Health Organization 10-point Clinical Progression Scale (WHO-CPS) on day 14

Secondary Outcome Measures

Survival rate

Proportion of transfer to intensive care unit (ICU)

Proportion of indication of transfer to intensive care unit (carried out or not in case of LATA)

Number of days living without mechanical ventilation

Number of days living without non-invasive ventilation and mechanical ventilation

Proportion of patient with a score higher than 6 on the World Health Organization 10-point Clinical Progression Scale

Duration of hospitalization

Proportion of patient in each category of the World Health Organization 10-point Clinical Progression Scale

Proportion of patient in each category of the National Early Warning Scale (NEWS) 2

Proportion of patient with a SARS-CoV-2 viral load detection

Mean evolution of blood count

Mean evolution of platelets

Mean evolution of blood ionogram

Mean evolution of glycemia

Mean evolution of serum creatinine

Mean evolution of C reactive protein

Mean evolution of Interleukin 6 (IL-6)

Mean evolution of oxygen requirements (number of liters / min)

Mean evolution of SaO2

Proportion of active smoker or active vapers or taking nicotine substitutes documented by examination

Proportion of active smoker or active vapers or taking nicotine substitutes documented by urinary cotinine

Mean score of Desire to smoke defined by French Tobacco Craving questionnaire (FTCQ12 )

Mean score of Cigarette Withdrawal Scale (CWS)

Mean score of Hospital anxiety and depression scale (HAD)

Mean score of Positive and Negative Affect Schedule (PANAS)

Mean score of Insomnia severity scale (ISI)

weight evolution

Full Information

NCT ID

NCT04608201

First Posted

October 23, 2020

Last Updated

February 10, 2022

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT04608201

Brief Title

Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Hospitalized Patients

Acronym

NICOVID

Official Title

Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Hospitalized Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

December 9, 2020 (Actual)

Primary Completion Date

November 5, 2021 (Actual)

Study Completion Date

November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The coronavirus disease (COVID-19) epidemic represents a major therapeutic challenge. The highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and the long duration of the disease have led to a massive influx of patients admitted in health services and intensive care units. To current knowledge, there is no treatment yet that that can prevent infection from SARS-COV-2 virus, nor the disease progression to a severe form. Daily active smokers are rare among outpatients or hospitalized COVID-19 patients. Several arguments suggest that nicotine could be responsible for this protective effect thank to the nicotinic acetylcholine receptor (nAChR). Based on epidemiological data and experimental data from scientific literature, we hypothesize that nicotine could inhibit the penetration and spread of the virus and improve the management of COVID19 , particularly in hospitalized patients to prevent adverse outcomes (death, transfer to intensive care unit, care limitation, mechanical ventilation an high flow oxygen).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

SARS-COV2

Keywords

SARS-COV2, COVID19, NICOTINE, transdermal patch

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NICOTINE transdermal patch

Arm Type

Experimental

Arm Description

NICOTINE 7 mg / 24h, transdermal patch

Arm Title

Placebo of NICOTINE transdermal patch

Arm Type

Placebo Comparator

Arm Description

Placebo of nicotine patch

Intervention Type

Drug

Intervention Name(s)

Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour

Intervention Description

Treatment involves escalating doses to the target dose of 14 mg / day / Dose escalation: Level 1: 3.5 mg/day (1/2 patch) for 2 days (D1 and D2) Level 2: 7 mg/day (1 patch) for 2 days (D3 and D4) Level 3: 10.5 mg/day (1.5 patch) for 2 days (D5 and D6) Level 4: target dose = 14 mg/day (from D7 to discharge from hospital + 1 week or maximum 5 weeks after the start of treatment) / Decrease in dose (1 week after exit from hospital or maximum 5 weeks after the start of treatment): Decrease of 3.5 mg (1/2 patch) per week (over 3 weeks maximum)

Intervention Type

Drug

Intervention Name(s)

Placebo of NICOTINE Transdermal patch

Intervention Description

Placebo of nicotine patch administered to the same administration schedule as in the experimental arm

Primary Outcome Measure Information:

Title

The unfavorable outcome on Day 14

Description

Defined by scores higher than 5 on the World Health Organization 10-point Clinical Progression Scale (WHO-CPS) on day 14

Time Frame

Day 14

Secondary Outcome Measure Information:

Title

Survival rate

Time Frame

Day 14, Day 28

Title

Proportion of transfer to intensive care unit (ICU)

Time Frame

Day 14, Day 28

Title

Proportion of indication of transfer to intensive care unit (carried out or not in case of LATA)

Time Frame

Day 14, Day 28

Title

Number of days living without mechanical ventilation

Time Frame

Day 14, Day 28

Title

Number of days living without non-invasive ventilation and mechanical ventilation

Time Frame

Day 4, Day 14, Day 28

Title

Proportion of patient with a score higher than 6 on the World Health Organization 10-point Clinical Progression Scale

Time Frame

Day 14

Title

Duration of hospitalization

Time Frame

Fom day 1 up to 3 month

Title

Proportion of patient in each category of the World Health Organization 10-point Clinical Progression Scale

Time Frame

Day 7, Day 14 and Day 28

Title

Proportion of patient in each category of the National Early Warning Scale (NEWS) 2

Time Frame

Day 7, Day14 and Day28 (or the day of discharge from hospital)

Title

Proportion of patient with a SARS-CoV-2 viral load detection

Time Frame

Day 7 or the day of discharge from hospital if before day 7

Title

Mean evolution of blood count

Time Frame