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

NCT04910230 | Completed

• 1 other identifier: N2020-12
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Lymphopenia

Keywords

nicotinamide; COVID19; lymphopenia

Outcome Measures

Primary Outcomes (1)

• changes in absolute lymphocyte counts

  the changes in absolute lymphocyte counts (\*10\^9/L) in before and 48 hours after treatment

  before and 48 hours after intervention

Secondary Outcomes (2)

• the death in hospital

  before and 48 hours after intervention

• the composite endpoint of aggravation

  before and 48 hours after intervention

Study Arms (2)

nicotinamide plus usual care

EXPERIMENTAL

Drug: nicotinamide

usual care

NO INTERVENTION

Interventions

nicotinamide DRUG

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

nicotinamide plus usual care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qiang Hu: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

Location

Related Publications (1)

• 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.

  PMID: 36316932 DERIVED

MeSH Terms

Conditions

COVID-19; Lymphopenia

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Quan-Yu L Zhang, phD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 2, 2021
• Study Start: March 1, 2020
• Primary Completion: April 2, 2020
• Study Completion: April 2, 2020
• Last Updated: November 8, 2021

Record last verified: 2021-10

Locations

CN (1)