COVID-19Phase 2NCT05765617
Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients
A Phase 2 study testing Calcitriol in people with COVID-19, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial summary
This research is a study that compares the administration of calcitriol with the outcomes of COVID-19 patients Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Calcitriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2021to 30 Sep 2021
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- COVID-19 patients, hospitalized patients, and patients aged 18-60 years
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Sebelas Maret Hospital
Sukoharjo, Central Java, 57161
About this study
This research is a study that compares the administration of calcitriol with the outcomes of COVID-19 patients
Read the detailed description
This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into two groups. The control group received standard therapy, while the treatment group received calcitriol 2x400 iu per day.
- Conditions
- COVID-19
- Being tested
- Calcitriol, Placebo
- Keywords
- calcitriol, HsCRP
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcitriolDrug
Also called Oscal
The treatment group received calcitriol 2x400 iu per day for five days. Calcitriol uses Oscal, obtained from Kalbe Pharma
PlaceboOther
Placebo give 2x1 per day for five day
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo 2x1 per day Receives: Other: Placebo |
| Calcitriol | Experimental | the treatment group received calcitriol 2x400 iu per day for 5 day Receives: Drug: Calcitriol |
What is being measured
The primary outcome is the main question the study is designed to answer.
HsCRP
High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation
Measured: Hs CRP (high sensitive c reactive protein) examination was carried out on the first day of hospitalization and the 5th day of hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Jul 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into two groups. The control group received standard therapy, while the treatment group received calcitriol 2x400 iu per day.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhasan Agung Prabowo, Universitas Sebelas Maret
- Investigators
- Nurhasan Agung Prabowo, MD, Principal investigator, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765617
- Sponsor's protocol ID
- NAP03
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients
- ClinicalTrials.gov ID
- NCT05765617
- Acronym / sponsor ID
- NAP03
- Conditions
- COVID-19
- Keywords
- calcitriol, HsCRP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 13 Mar 2023 (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.
This research is a study that compares the administration of calcitriol with the outcomes of COVID-19 patients
Detailed description
This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into two groups. The control group received standard therapy, while the treatment group received calcitriol 2x400 iu per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into two groups. The control group received standard therapy, while the treatment group received calcitriol 2x400 iu per day.
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: PlaceboPlacebo 2x1 per day |
| Calcitriol | Experimental | Drug: Calcitriolthe treatment group received calcitriol 2x400 iu per day for 5 day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- COVID-19 patients, hospitalized patients, and patients aged 18-60 years
Key exclusion criteria (1 listed)
- pregnancy
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 |
|---|---|---|
| CalcitriolAlso: OscalThe treatment group received calcitriol 2x400 iu per day for five days. Calcitriol uses Oscal, obtained from Kalbe Pharma | Drug | Calcitriol |
| PlaceboPlacebo give 2x1 per day for five day | Other | Control |
Primary outcome
HsCRP
Time frame: Hs CRP (high sensitive c reactive protein) examination was carried out on the first day of hospitalization and the 5th day of hospitalization
High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation
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 13 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Nurhasan Agung Prabowo, MD principal investigator
Universitas Sebelas Maret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcitriol in people with COVID-19, run by Universitas Sebelas Maret at 1 site in Indonesia.
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 1 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 13 Mar 2023. 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 Indonesia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
HsCRP (time frame: Hs CRP (high sensitive c reactive protein) examination was carried out on the first day of hospitalization and the 5th day of hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2023.