Back to resultsNicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19
Primary Purpose
Covid19, Lymphopenia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nicotinamide
Sponsored by
About this trial
This is an interventional supportive care trial for Covid19 focused on measuring nicotinamide, COVID19, lymphopenia
Eligibility Criteria
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.
Sites / Locations
- General Hospital of Northern Theater Command
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
nicotinamide plus usual care
usual care
Arm Description
Outcomes
Primary Outcome Measures
changes in absolute lymphocyte counts
the changes in absolute lymphocyte counts (*10^9/L) in before and 48 hours after treatment
Secondary Outcome Measures
the death in hospital
the rate of death in hospital (%)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04910230
Brief Title
Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19
Official Title
Efficiency and Safety of Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
April 2, 2020 (Actual)
Study Completion Date
April 2, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qiang Hu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Lymphopenia
Keywords
nicotinamide, COVID19, lymphopenia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nicotinamide plus usual care
Arm Type
Experimental
Arm Title
usual care
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
nicotinamide
Intervention Description
In addition to usual care, the treatment group was given 500mg nicotinamide daily, divided into 5 doses
Primary Outcome Measure Information:
Title
changes in absolute lymphocyte counts
Description
the changes in absolute lymphocyte counts (*10^9/L) in before and 48 hours after treatment
Time Frame
before and 48 hours after intervention
Secondary Outcome Measure Information:
Title
the death in hospital
Description
the rate of death in hospital (%)
Time Frame
before and 48 hours after intervention
Title
the composite endpoint of aggravation
Description
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.
Time Frame
before and 48 hours after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan-Yu L Zhang, phD
Organizational Affiliation
Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Northern Theater Command
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110016
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
36316932
Citation
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.
Results Reference
derived
Learn more about this trial
Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19
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