Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19

NCT ID: NCT04910230

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-04-02

Brief Summary

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The mechanism of peripheral blood lymphocyte decline in COVID-19 patients is not yet clear. However, one theory demonstrated that in the whole progression of COVID-19, the extensive activation of poly-ADP-ribose polymerase (PARP) may reduce the cellular NAD+ and dampen the adaptive immune system. So investigators presume that replenishing the NAD+ using nicotinamide as the precursor may improve the lymphocyte counts and boost the adaptive immune system. As a result, the study using nicotinamide as a kind of supportive therapy provide further evidence of their efficiency and safety in treating lymphopenia in patients with COVID-19.

Detailed Description

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Conditions

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Covid19 Lymphopenia

Keywords

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nicotinamide COVID19 lymphopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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nicotinamide plus usual care

Group Type EXPERIMENTAL

nicotinamide

Intervention Type DRUG

In addition to usual care, the treatment group was given 500mg nicotinamide daily, divided into 5 doses

usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nicotinamide

In addition to usual care, the treatment group was given 500mg nicotinamide daily, divided into 5 doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* the patients diagnosed as the common or severe cases of COVID-19
* aged 18-85
* the absolute lymphocyte counts below the normal value (\<1.1-3.2×109/L)

Exclusion Criteria

* the patients who are diagnosed as critically ill cases or participating in other clinical trials
* women who are pregnant or lactating
* ALT/AST \> 5 times upper limit of normal (ULN), neutrophils counts \< 0.5×109/L, platelets counts\< 50×109/L
* patients diagnosed with rheumatoid immune-related diseases
* patients who take long-term oral anti-rejection drugs or immunomodulatory drugs
* hypersensitive reaction to nicotinamide or any auxiliary materials
* patients with active tuberculosis or combined with bacterial and fungal infections
* patients undergoing organ transplant
* patients with mental disorders.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qiang Hu

OTHER

Sponsor Role lead

Responsible Party

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Qiang Hu

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Quan-Yu L Zhang, phD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China

Locations

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General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Site Status

Countries

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China

References

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Hu Q, Zhang QY, Peng CF, Ma Z, Han YL. Efficiency of nicotinamide-based supportive therapy in lymphopenia for patients with ordinary or severe COVID-19: A randomized controlled trial. Medicine (Baltimore). 2022 Oct 28;101(43):e31138. doi: 10.1097/MD.0000000000031138.

Reference Type DERIVED
PMID: 36316932 (View on PubMed)

Other Identifiers

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N2020-12

Identifier Type: -

Identifier Source: org_study_id