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

Q

Qiang Hu

Status

Completed

Conditions

Lymphopenia
Covid19

Treatments

Drug: nicotinamide

Study type

Interventional

Funder types

Other

Identifiers

NCT04910230
N2020-12

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups

nicotinamide plus usual care
Experimental group
Treatment:
Drug: nicotinamide
usual care
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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