Covid19NCT04910230
Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19
A study testing nicotinamide in people with Covid19 and Lymphopenia, run by Qiang Hu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Covid19, Lymphopenia
- What is being tested?
- nicotinamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 2 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- patients with active tuberculosis or combined with bacterial and fungal infections
- patients undergoing organ transplant
- patients with mental disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
About this study
Official title: Efficiency and Safety of Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19: A Randomized Clinical Trial
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.
- Conditions
- Covid19, Lymphopenia
- Being tested
- nicotinamide
- Keywords
- nicotinamide, COVID19, lymphopenia
- Medical subject headings
- COVID-19, Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nicotinamideDrug
In addition to usual care, the treatment group was given 500mg nicotinamide daily, divided into 5 doses
| Study group | Role | What they receive |
|---|---|---|
| nicotinamide plus usual care | Experimental | Not described Receives: Drug: nicotinamide |
| usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in absolute lymphocyte counts
the changes in absolute lymphocyte counts (*10^9/L) in before and 48 hours after treatment
Measured: before and 48 hours after intervention
Secondary outcomes (2)
the death in hospital
the rate of death in hospital (%)
Measured: 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.
Measured: before and 48 hours after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 Mar 2020
- Primary completion2 Apr 2020
- Study completion2 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qiang Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qiang Hu, Shenyang Northern Hospital
- Investigators
- Quan-Yu L Zhang, phD, Principal investigator, Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910230
- Sponsor's protocol ID
- N2020-12
- Status last verified
- Oct 2021
- First submitted
- 24 May 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36316932
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety of Nicotinamide-based Supportive Therapy in Lymphopenia for Patients With COVID-19: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04910230
- Acronym / sponsor ID
- N2020-12
- Conditions
- Covid19, Lymphopenia
- Keywords
- nicotinamide, COVID19, lymphopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Qiang HuUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nicotinamide plus usual care | Experimental | Drug: nicotinamide |
| usual care | No intervention | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nicotinamideIn addition to usual care, the treatment group was given 500mg nicotinamide daily, divided into 5 doses | Drug | nicotinamide plus usual care |
Primary outcome
changes in absolute lymphocyte counts
Time frame: before and 48 hours after intervention
the changes in absolute lymphocyte counts (*10^9/L) in before and 48 hours after treatment
2 secondary outcomes
the death in hospital
Time frame: before and 48 hours after intervention
the composite endpoint of aggravation
Time frame: before and 48 hours after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Derived from this study: PubMed 36316932Hu 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quan-Yu L Zhang, phD principal investigator
Department of Cardiology, General Hospital of Northern Theater Command, Shenyang 110016, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nicotinamide in people with Covid19 and Lymphopenia, run by Qiang Hu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in absolute lymphocyte counts (time frame: before and 48 hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04910230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.