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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04910230
Other study ID # N2020-12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2020
Est. completion date April 2, 2020

Study information

Verified date October 2021
Source Shenyang Northern Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date April 2, 2020
Est. primary completion date April 2, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
China General Hospital of Northern Theater Command Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
Qiang Hu

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 the death in hospital the rate of death in hospital (%) before and 48 hours after intervention
Secondary the composite endpoint of aggravation 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. before and 48 hours after intervention
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