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

Not Applicable

Completed

• Conditions: Lymphopenia; Covid19
• Interventions: Drug: nicotinamide

• Registration Number: NCT04910230
• Lead Sponsor: Qiang Hu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2020-04-02
• Study Completion: 2020-04-02
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-02
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nicotinamide plus usual care	nicotinamide	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
the death in hospital	before and 48 hours after intervention	the rate of death in hospital (%)
the composite endpoint of aggravation	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.

Trial Locations

Locations (1)

General Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China