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

Sponsor

Qiang Hu (Other)

Overall Status

Completed

CT.gov ID

NCT04910230

Collaborator

(none)

Enrollment

Location

Arms

1.1

Actual Duration (Months)

22.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Lymphopenia	Drug: nicotinamide	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Actual Primary Completion Date :

Apr 2, 2020

Actual Study Completion Date :

Apr 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: nicotinamide plus usual care	Drug: nicotinamide In addition to usual care, the treatment group was given 500mg nicotinamide daily, divided into 5 doses
No Intervention: usual care

Arm

Intervention/Treatment

Experimental: nicotinamide plus usual care

Drug: nicotinamide

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

No Intervention: usual care

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.