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

October 29, 2021 updated by: Qiang Hu

Efficiency and Safety of Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19: A Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • General Hospital of Northern Theater Command

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: usual care
Experimental: nicotinamide plus usual care
Drug: nicotinamide
In addition to usual care, the treatment group was given 500mg nicotinamide daily, divided into 5 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in absolute lymphocyte counts
Time Frame: before and 48 hours after intervention
the changes in absolute lymphocyte counts (*10^9/L) in before and 48 hours after treatment
before and 48 hours after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the death in hospital
Time Frame: before and 48 hours after intervention
the rate of death in hospital (%)
before and 48 hours after intervention
the composite endpoint of aggravation
Time Frame: before and 48 hours after intervention
the rate of composite endpoint of aggravation(%) , according to upgraded oxygen therapy, improvement of nursing level, and ward rounds of superior physicians for changes of conditions using the time to event principle. The upgraded oxygen therapy, improvement of nursing level, and ward rounds of superior physicians for changes of conditions would be combined to the composite endpoint in percentage (%). The upgraded oxygen therapy was defined as upgrading of ge neral high-volume oxygen intake from oxygen intake, ventilator using from high-volume oxygen intake or transference to intensive care unit from ventilator using.
before and 48 hours after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qiang Hu

Investigators

  • Principal Investigator: Quan-Yu L Zhang, phD, Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

April 2, 2020

Study Completion (Actual)

April 2, 2020

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 2, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N2020-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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