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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04910230
• Other study ID #: N2020-12
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Lymphopenia

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