SARS-CoV2 InfectionCOVID-VITNCT05092698
The Efficacy of Vitamin D Supplementation in Patients With Severe and Extremely Severe COVID-19
A study testing Vitamin D (cholecalciferol) and Herbal oil in people with SARS-CoV2 Infection, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.
Trial summary
Despite the successful treatment of patients with moderate coronavirus disease 2019 (COVID-19), outcomes for patients with severe disease remain unsatisfactory. In this category of patients, the course of the disease is complicated by the development of acute respiratory distress syndrome (ARDS) and the need for… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- Vitamin D (cholecalciferol) and Herbal oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteRussia
- Study dates
- 1 May 2020to 31 Jan 2022
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients with COVID-19 admitted to the ICU with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤ 30 ng/ml]
Who cannot join
- less than 24 hours in ICU by any reason
- chronic decompensated disease with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure) with a life expectancy of less than 48 hours
- atonic coma
- allergic reaction on cholecalciferol or herbal oil
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Research Clinical Center of Federal Medical & Biological Agency
Moscow, 115682
About this study
Despite the successful treatment of patients with moderate coronavirus disease 2019 (COVID-19), outcomes for patients with severe disease remain unsatisfactory. In this category of patients, the course of the disease is complicated by the development of acute respiratory distress syndrome (ARDS) and the need for mechanical ventilation in the intensive care unit (ICU). Mortality in this category of patients reaches 85%. The lack of effective treatment for COVID-19 has prompted scientists to look for new strategies to reduce the incidence and severity of COVID-19, disease progression, and mortality.
Disease severity and mortality rates due to COVID-19 infection are greater in the elderly and chronically ill patients, populations at high risk for vitamin D deficiency. Vitamin D plays an important role in immune function and inflammation.
Read more
A number of experimental studies have shown that stimulation of vitamin D receptors can improve the course of ARDS due to inhibition of the hyperimmune inflammatory response, regulation of the renin-angiotensin system, modulation of neutrophil activity, maintenance of the integrity of the pulmonary epithelial barrier and stimulation of epithelial repair, as well as by reducing hypercoagulation.
Several studies on ICU patients have reported that low vitamin D (25(OH)D) concentrations are associated with a higher risk of negative outcomes such as death, organ failure, prolonged mechanical ventilation, a higher rate of ventilation-associated pneumonia, and sepsis.
While the available evidence to-date, from largely poor-quality observational studies, may be viewed as showing a trend for an association between low serum 25(OH)D levels and COVID-19 related health outcomes, this relationship was not found to be statistically significant. Calcifediol supplementation may have a protective effect on COVID-19 related ICU admissions.
Read the detailed description
The aim of the study is to evaluate the efficacy of vitamin D (cholecalciferol) supplementation in patients with severe and extremely severe disease caused by the SARS-CoV-2 virus, admitted to an ICU of the COVID-center on the first day and in dynamics until discharge from the hospital or death. Patients with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤ 30 ng/ml] will be randomized to two groups: 1 - patients will receive 60,000 IU of cholecalciferol supplementation; 2 - patients will receive matched placebo.
The demographic and clinical data will be collected. Laboratory data (hemoglobin, lymphocytes, neutrophil to lymphocyte ratio, D-dimer level, Interleukin-6, procalcitonin, ferritin, glucose level, high-sensitive troponin Т, vitamin D level (25(OH)D), acid-base balance, signs of a secondary bacterial infection, immunogram, Von Willebrand factor antigen and Instrumental data (CT-scan, Electrocardiography, echocardiography, arterial and venous ultrasound investigation) will be analysed. The frequency of complications, duration of mechanical ventilation, length of stay in the ICU and in the hospital, and mortality will be evaluated.
This study is single-centre prospective randomized placebo-controlled trial.
- Conditions
- SARS-CoV2 Infection
- Being tested
- Vitamin D (cholecalciferol), Herbal oil
- Keywords
- severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), coronavirus disease 2019 (COVID-19), severe and extremely severe disease, Vitamin D, cholecalciferol
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D (cholecalciferol)Dietary supplement
Patients will receive 60,000 IU of cholecalciferol dissolved in 45 ml herbal oil orally or via feeding tube after serum Vitamin D concentrations measurement followed by the same dose of cholecalciferol weekly and 5,000 IU of cholecalciferol (two drops) daily until discharge or death.
Herbal oilDietary supplement
Also called Placebo
Patients will receive 45 ml of herbal oil orally or via feeding tube after serum Vitamin D concentrations measurement followed by the same dose of pure herbal oil weekly and two drops of herbal oil daily until discharge or death.
| Study group | Role | What they receive |
|---|---|---|
| Vit_D_suppl | Active comparator | Patients will receive 60,000 IU of cholecalciferol dissolved in 45 ml herbal oil orally or via feeding tube weekly followed by 5,000 IU of cholecalciferol (two drops) daily until discharge or death. Receives: Dietary Supplement: Vitamin D (cholecalciferol) |
| Vit_D_placebo | Placebo comparator | Patients will receive 45 ml of herbal oil orally or via feeding tube followed by 45 ml of herbal oil weekly followed by two drops of herbal oil daily until discharge or death. Receives: Dietary Supplement: Herbal oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Сomplete blood count
Сomplete blood count
Measured: Change from baseline on day 5 during ICU treatment
Сomplete blood count dynamics 1
Сomplete blood count
Measured: Change from baseline on day 10 during ICU treatment
Сomplete blood count dynamics 2
Сomplete blood count
Measured: Change from baseline on day 15 during ICU treatment
Сomplete blood count dynamics 3
Сomplete blood count
Measured: Change from baseline on day 21 during ICU treatment
C-reactive protein
Concentration of C-reactive protein
Measured: Change from baseline on day 5 during ICU treatment
C-reactive protein 1
Concentration of C-reactive protein
Measured: Change from baseline on day 10 during ICU treatment
C-reactive protein 2
Concentration of C-reactive protein
Measured: Change from baseline on day 15 during ICU treatment
C-reactive protein 3
Concentration of C-reactive protein
Measured: Change from baseline on day 21 during ICU treatment
Von Willebrand factor antigen
Concentration of Von Willebrand factor antigen
Measured: Change from baseline on day 7 during ICU treatment
Thrombotic complications
Arterial or venous thrombotic complications
Measured: 60 days
Immunogram
The amount of NKT cells (CD3+CD56+CD16+), NK cells (CD3-CD56+CD16+)
Measured: Change from baseline on day 7 during ICU treatment
Proinflammatory marker
Concentration of D-dimer
Measured: Change from baseline on day 5 during ICU treatment
Proinflammatory marker 1
Concentration of D-dimer
Measured: on day 10 during ICU treatment
Proinflammatory marker 2
Concentration of D-dimer
Measured: on day 15 during ICU treatment
Proinflammatory marker 3
Concentration of D-dimer
Measured: on day 21 during ICU treatment
inflammatory marker
Concentration of Interleukin-6
Measured: Change from baseline on day 5 during ICU treatment
inflammatory marker 1
Concentration of Interleukin-6
Measured: Change from baseline on day 10 during ICU treatment
inflammatory marker 2
Concentration of Interleukin-6
Measured: Change from baseline on day 15 during ICU treatment
inflammatory marker 3
Concentration of Interleukin-6
Measured: Change from baseline on day 21 during ICU treatment
Infection marker
Concentration of Procalcitonin
Measured: Change from baseline on day 5 during ICU treatment
Infection marker 1
Concentration of Procalcitonin
Measured: Change from baseline on day 10 during ICU treatment
Secondary outcomes (6)
Mortality
The dead and survived patients ratio
Measured: 60 days
Mechanical ventilation duration
The amount of mechanical ventilation days
Measured: 30 days
Non-invasive Mechanical ventilation duration
The amount of Non-invasive mechanical ventilation days
Measured: 30 days
Length of stay in the ICU
The amount of day of ICU treatment
Measured: 60 days
Length of stay in the hospital
The amount of day of hospital treatment
Measured: 60 days
Infection complications
The amount of Infection complications
Measured: 60 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start1 May 2020
- Primary completion31 Dec 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV2 InfectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tatiana V Klypa, ScD, Study chair, Federal Research Clinical Center of Federal Medical & Biological Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092698
- Sponsor's protocol ID
- COVID-VIT
- Acronym
- COVID-VIT
- Status last verified
- Nov 2021
- First submitted
- 22 Oct 2021
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bassatne A, Basbous M, Chakhtoura M, El Zein O, Rahme M, El-Hajj Fuleihan G. The link between COVID-19 and VItamin D (VIVID): A systematic review and meta-analysis. Metabolism. 2021 Jun;119:154753. doi: 10.1016/j.metabol.2021.154753. Epub 2021 Mar 24.
PubMed 33774074Bychinin MV, Klypa TV, Mandel IA, Andreichenko SA, Baklaushev VP, Yusubalieva GM, Kolyshkina NA, Troitsky AV. Low Circulating Vitamin D in Intensive Care Unit-Admitted COVID-19 Patients as a Predictor of Negative Outcomes. J Nutr. 2021 Aug 7;151(8):2199-2205. doi: 10.1093/jn/nxab107.
PubMed 33982128Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
PubMed 32109013Kong J, Zhu X, Shi Y, Liu T, Chen Y, Bhan I, Zhao Q, Thadhani R, Li YC. VDR attenuates acute lung injury by blocking Ang-2-Tie-2 pathway and renin-angiotensin system. Mol Endocrinol. 2013 Dec;27(12):2116-25. doi: 10.1210/me.2013-1146. Epub 2013 Nov 6.
PubMed 24196349Bychinin MV, Klypa TV, Mandel IA, Yusubalieva GM, Baklaushev VP, Kolyshkina NA, Troitsky AV. Effect of vitamin D3 supplementation on cellular immunity and inflammatory markers in COVID-19 patients admitted to the ICU. Sci Rep. 2022 Nov 3;12(1):18604. doi: 10.1038/s41598-022-22045-y.
PubMed 36329227
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Vitamin D Supplementation in Patients With Severe and Extremely Severe COVID-19
- ClinicalTrials.gov ID
- NCT05092698
- Acronym / sponsor ID
- COVID-VIT / COVID-VIT
- Conditions
- SARS-CoV2 Infection
- Keywords
- severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), coronavirus disease 2019 (COVID-19), severe and extremely severe disease, Vitamin D, cholecalciferol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Federal Research Clinical Center of Federal Medical & Biological Agency, RussiaOther government
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 25 Oct 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.
Despite the successful treatment of patients with moderate coronavirus disease 2019 (COVID-19), outcomes for patients with severe disease remain unsatisfactory. In this category of patients, the course of the disease is complicated by the development of acute respiratory distress syndrome (ARDS) and the need for mechanical ventilation in the intensive care unit (ICU). Mortality in this category of patients reaches 85%. The lack of effective treatment for COVID-19 has prompted scientists to look for new strategies to reduce the incidence and severity of COVID-19, disease progression, and mortality.
Disease severity and mortality rates due to COVID-19 infection are greater in the elderly and chronically ill patients, populations at high risk for vitamin D deficiency. Vitamin D plays an important role in immune function and inflammation.
A number of experimental studies have shown that stimulation of vitamin D receptors can improve the course of ARDS due to inhibition of the hyperimmune inflammatory response, regulation of the renin-angiotensin system, modulation of neutrophil activity, maintenance of the integrity of the pulmonary epithelial barrier and stimulation of epithelial repair, as well as by reducing hypercoagulation.
Several studies on ICU patients have reported that low vitamin D (25(OH)D) concentrations are associated with a higher risk of negative outcomes such as death, organ failure, prolonged mechanical ventilation, a higher rate of ventilation-associated pneumonia, and sepsis.
While the available evidence to-date, from largely poor-quality observational studies, may be viewed as showing a trend for an association between low serum 25(OH)D levels and COVID-19 related health outcomes, this relationship was not found to be statistically significant. Calcifediol supplementation may have a protective effect on COVID-19 related ICU admissions.
Detailed description
The aim of the study is to evaluate the efficacy of vitamin D (cholecalciferol) supplementation in patients with severe and extremely severe disease caused by the SARS-CoV-2 virus, admitted to an ICU of the COVID-center on the first day and in dynamics until discharge from the hospital or death. Patients with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤ 30 ng/ml] will be randomized to two groups: 1 - patients will receive 60,000 IU of cholecalciferol supplementation; 2 - patients will receive matched placebo.
The demographic and clinical data will be collected. Laboratory data (hemoglobin, lymphocytes, neutrophil to lymphocyte ratio, D-dimer level, Interleukin-6, procalcitonin, ferritin, glucose level, high-sensitive troponin Т, vitamin D level (25(OH)D), acid-base balance, signs of a secondary bacterial infection, immunogram, Von Willebrand factor antigen and Instrumental data (CT-scan, Electrocardiography, echocardiography, arterial and venous ultrasound investigation) will be analysed. The frequency of complications, duration of mechanical ventilation, length of stay in the ICU and in the hospital, and mortality will be evaluated.
This study is single-centre prospective randomized placebo-controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vit_D_suppl | Active comparator | Dietary Supplement: Vitamin D (cholecalciferol)Patients will receive 60,000 IU of cholecalciferol dissolved in 45 ml herbal oil orally or via feeding tube weekly followed by 5,000 IU of cholecalciferol (two drops) daily until discharge or death. |
| Vit_D_placebo | Placebo comparator | Dietary Supplement: Herbal oilPatients will receive 45 ml of herbal oil orally or via feeding tube followed by 45 ml of herbal oil weekly followed by two drops of herbal oil daily until discharge or death. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with COVID-19 admitted to the ICU with vitamin D deficiency [25-hydroxyvitamin D (25(OH)D) ≤ 30 ng/ml]
Key exclusion criteria (4 listed)
- less than 24 hours in ICU by any reason
- chronic decompensated disease with extrapulmonary organ dysfunction (tumour progression, liver cirrhosis, congestive heart failure) with a life expectancy of less than 48 hours
- atonic coma
- allergic reaction on cholecalciferol or herbal oil
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 |
|---|---|---|
| Vitamin D (cholecalciferol)Patients will receive 60,000 IU of cholecalciferol dissolved in 45 ml herbal oil orally or via feeding tube after serum Vitamin D concentrations measurement followed by the same dose of cholecalciferol weekly and 5,000 IU of cholecalciferol (two drops) daily until discharge or death. | Dietary supplement | Vit_D_suppl |
| Herbal oilAlso: PlaceboPatients will receive 45 ml of herbal oil orally or via feeding tube after serum Vitamin D concentrations measurement followed by the same dose of pure herbal oil weekly and two drops of herbal oil daily until discharge or death. | Dietary supplement | Vit_D_placebo |
Primary outcome
Сomplete blood count
Time frame: Change from baseline on day 5 during ICU treatment
Сomplete blood count
Сomplete blood count dynamics 1
Time frame: Change from baseline on day 10 during ICU treatment
Сomplete blood count
Сomplete blood count dynamics 2
Time frame: Change from baseline on day 15 during ICU treatment
Сomplete blood count
Сomplete blood count dynamics 3
Time frame: Change from baseline on day 21 during ICU treatment
Сomplete blood count
C-reactive protein
Time frame: Change from baseline on day 5 during ICU treatment
Concentration of C-reactive protein
C-reactive protein 1
Time frame: Change from baseline on day 10 during ICU treatment
Concentration of C-reactive protein
C-reactive protein 2
Time frame: Change from baseline on day 15 during ICU treatment
Concentration of C-reactive protein
C-reactive protein 3
Time frame: Change from baseline on day 21 during ICU treatment
Concentration of C-reactive protein
Von Willebrand factor antigen
Time frame: Change from baseline on day 7 during ICU treatment
Concentration of Von Willebrand factor antigen
Thrombotic complications
Time frame: 60 days
Arterial or venous thrombotic complications
Immunogram
Time frame: Change from baseline on day 7 during ICU treatment
The amount of NKT cells (CD3+CD56+CD16+), NK cells (CD3-CD56+CD16+)
Proinflammatory marker
Time frame: Change from baseline on day 5 during ICU treatment
Concentration of D-dimer
Proinflammatory marker 1
Time frame: on day 10 during ICU treatment
Concentration of D-dimer
Proinflammatory marker 2
Time frame: on day 15 during ICU treatment
Concentration of D-dimer
Proinflammatory marker 3
Time frame: on day 21 during ICU treatment
Concentration of D-dimer
inflammatory marker
Time frame: Change from baseline on day 5 during ICU treatment
Concentration of Interleukin-6
inflammatory marker 1
Time frame: Change from baseline on day 10 during ICU treatment
Concentration of Interleukin-6
inflammatory marker 2
Time frame: Change from baseline on day 15 during ICU treatment
Concentration of Interleukin-6
inflammatory marker 3
Time frame: Change from baseline on day 21 during ICU treatment
Concentration of Interleukin-6
Infection marker
Time frame: Change from baseline on day 5 during ICU treatment
Concentration of Procalcitonin
Infection marker 1
Time frame: Change from baseline on day 10 during ICU treatment
Concentration of Procalcitonin
6 secondary outcomes
Mortality
Time frame: 60 days
Mechanical ventilation duration
Time frame: 30 days
Non-invasive Mechanical ventilation duration
Time frame: 30 days
Length of stay in the ICU
Time frame: 60 days
Length of stay in the hospital
Time frame: 60 days
Infection complications
Time frame: 60 day
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 7 Mar 2022.
- Background: PubMed 33774074Bassatne A, Basbous M, Chakhtoura M, El Zein O, Rahme M, El-Hajj Fuleihan G. The link between COVID-19 and VItamin D (VIVID): A systematic review and meta-analysis. Metabolism. 2021 Jun;119:154753. doi: 10.1016/j.metabol.2021.154753. Epub 2021 Mar 24.
- Background: PubMed 33982128Bychinin MV, Klypa TV, Mandel IA, Andreichenko SA, Baklaushev VP, Yusubalieva GM, Kolyshkina NA, Troitsky AV. Low Circulating Vitamin D in Intensive Care Unit-Admitted COVID-19 Patients as a Predictor of Negative Outcomes. J Nutr. 2021 Aug 7;151(8):2199-2205. doi: 10.1093/jn/nxab107.
- Background: PubMed 32109013Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
- Background: PubMed 24196349Kong J, Zhu X, Shi Y, Liu T, Chen Y, Bhan I, Zhao Q, Thadhani R, Li YC. VDR attenuates acute lung injury by blocking Ang-2-Tie-2 pathway and renin-angiotensin system. Mol Endocrinol. 2013 Dec;27(12):2116-25. doi: 10.1210/me.2013-1146. Epub 2013 Nov 6.
- Derived from this study: PubMed 36329227Bychinin MV, Klypa TV, Mandel IA, Yusubalieva GM, Baklaushev VP, Kolyshkina NA, Troitsky AV. Effect of vitamin D3 supplementation on cellular immunity and inflammatory markers in COVID-19 patients admitted to the ICU. Sci Rep. 2022 Nov 3;12(1):18604. doi: 10.1038/s41598-022-22045-y.
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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.
Tatiana V Klypa, ScD study chair
Federal Research Clinical Center of Federal Medical & Biological Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D (cholecalciferol) and Herbal oil in people with SARS-CoV2 Infection, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.
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 1 inclusion and 4 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 7 Mar 2022. 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 Russia. 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. Some participants in this study may receive a placebo. 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?
Сomplete blood count (time frame: Change from baseline on day 5 during ICU treatment). The study lists 21 primary outcomes in all. 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 NCT05092698, which also lists 5 linked publications.
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 7 Mar 2022.