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

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Brief Title

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

Official Title

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

Brief Summary

      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 Type

Interventional


Primary Outcome

changes in absolute lymphocyte counts

Secondary Outcome

 the death in hospital

Condition

Covid19

Intervention

nicotinamide

Study Arms / Comparison Groups

 nicotinamide plus usual care
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

24

Start Date

March 1, 2020

Completion Date

April 2, 2020

Primary Completion Date

April 2, 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Quan-Yu L Zhang, phD, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04910230

Organization ID

N2020-12


Responsible Party

Sponsor-Investigator

Study Sponsor

Qiang Hu


Study Sponsor

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


Verification Date

October 2021