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| Column | Value |
|---|---|
| Trial registration number | NCT04910230 |
|
Full text link
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2021-06-02 |
|
Recruitment status
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
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
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
- 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. |
|
Number of arms
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Qiang Hu |
|
Inclusion age min
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
85 |
|
Countries
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
China |
|
Type of patients
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
|
Total sample size
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
24 |
|
primary outcome
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
changes in absolute lymphocyte counts |
|
Notes
Last imported at : June 4, 2021, 12:32 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Arms
Last imported at : March 27, 2022, 4 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 885, "treatment_name": "Nicotinamide", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |