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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nicotinamide plus usual care | Experimental |
| |
| usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nicotinamide | Drug | In addition to usual care, the treatment group was given 500mg nicotinamide daily, divided into 5 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the death in hospital | the rate of death in hospital (%) | before and 48 hours after intervention |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quan-Yu L Zhang, phD | Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Northern Theater Command | Shenyang | Liaoning | 110016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36316932 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D008231 | Lymphopenia |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| before and 48 hours after intervention |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |