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OpenTrials
Completed

NCT Number: NCT04910230

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Leukocyte Disorders Leukopenia Lung Diseases Lymphopenia Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotinamide

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. the death in hospital

    Time frame: before and 48 hours after intervention

    the rate of death in hospital (%)

  2. 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.

Sponsors and collaborators

Lead sponsor

Qiang Hu

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 2, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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