COVID-19Phase 2NCT04360980
The Effects of Standard Protocol With or Without Colchicine in Covid-19 Infection
A Phase 2 study testing Colchicine Tablets in people with COVID-19, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
Trial summary
Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Colchicine Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesIran
- Study dates
- 20 Mar 2020to 30 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years old with nasopharyngeal swab confirmed COVID-19 PCR, CT involvement compatible with COVID, Fever and Dyspnea without hypoxemia.
Who cannot join
- Patient who is not willing to enter in study
- Known hypersensitivity to colchicine
- Hepatic failure
- Renal failure with eGFR<20 ml/min
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial
Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .
Read the detailed description
80 Patients with positive nasopharyngeal swab PCR for COVID-19 which were not hypoxic but showed computed tomography involvement compatible with COVID-19 admitted in ward (not in Intensive care unit) included and randomized in to two groups. All patients received standard treatment protocol including essential minerals, vitamins as antioxidants, antibiotics and Kaletra while in one randomly assigned group colchicine would be added.
- Conditions
- COVID-19
- Being tested
- Colchicine Tablets
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine TabletsDrug
Also called Colchicine
1.5 mg loading then 0.5 mg BID P.O
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 40 RT-PCR positive COVID-19 patients without hypoxemia administered Colchicine plus standard treatment Receives: Drug: Colchicine Tablets |
| Standard treatment | No intervention | 40 RT-PCR positive COVID-19 patients without hypoxemia receiving vitamin C 3grams daily , 400 mg Tiamine, Selenium , Omega-3 500 mg daily, Vit A , Vit D, Azithromycine, Ceftriaxone, Kaletra 400 BID 10 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRPxN/R ratio change
increasing inflammatory status
Measured: 2 weeks
Clinical deterioration by the WHO definition
including change in fever or O2 Saturation
Measured: 2 weeks
PCR Viral Load
change in RT-PCR
Measured: 2 weeks
CT severity involvement index
change in CT involvement
Measured: 2weeks
Secondary outcomes (1)
LDH change
change in LDH
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start20 Mar 2020
- Primary completion1 Jan 2021
- Study completion30 Jan 2021
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 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
- Investigators
- SBMU, Principal investigator, CKDRC,SBMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360980
- Sponsor's protocol ID
- SBMU.IR.REC.165423
- Status last verified
- Jan 2022
- First submitted
- 22 Apr 2020
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dalili N, Kashefizadeh A, Nafar M, Poorrezagholi F, Firouzan A, Samadian F, Samavat S, Ziaie S, Fatemizadeh S. Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial. Trials. 2020 Jun 5;21(1):489. doi: 10.1186/s13063-020-04455-3.
PubMed 32503620
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Standard Protocol Therapy With or Without Colchicine in Covid-19 Infection: A Randomized Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04360980
- Acronym / sponsor ID
- SBMU.IR.REC.165423
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 24 Apr 2020 (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.
Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .
Detailed description
80 Patients with positive nasopharyngeal swab PCR for COVID-19 which were not hypoxic but showed computed tomography involvement compatible with COVID-19 admitted in ward (not in Intensive care unit) included and randomized in to two groups. All patients received standard treatment protocol including essential minerals, vitamins as antioxidants, antibiotics and Kaletra while in one randomly assigned group colchicine would be added.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Drug: Colchicine Tablets40 RT-PCR positive COVID-19 patients without hypoxemia administered Colchicine plus standard treatment |
| Standard treatment | No intervention | –40 RT-PCR positive COVID-19 patients without hypoxemia receiving vitamin C 3grams daily , 400 mg Tiamine, Selenium , Omega-3 500 mg daily, Vit A , Vit D, Azithromycine, Ceftriaxone, Kaletra 400 BID 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients >18 years old with nasopharyngeal swab confirmed COVID-19 PCR, CT involvement compatible with COVID, Fever and Dyspnea without hypoxemia.
Key exclusion criteria (4 listed)
- Patient who is not willing to enter in study
- Known hypersensitivity to colchicine
- Hepatic failure
- Renal failure with eGFR<20 ml/min
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 |
|---|---|---|
| Colchicine TabletsAlso: Colchicine1.5 mg loading then 0.5 mg BID P.O | Drug | Intervention |
Primary outcome
CRPxN/R ratio change
Time frame: 2 weeks
increasing inflammatory status
Clinical deterioration by the WHO definition
Time frame: 2 weeks
including change in fever or O2 Saturation
PCR Viral Load
Time frame: 2 weeks
change in RT-PCR
CT severity involvement index
Time frame: 2weeks
change in CT involvement
1 secondary outcome
LDH change
Time frame: 2 weeks
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 28 Jan 2022.
- Derived from this study: PubMed 32503620Dalili N, Kashefizadeh A, Nafar M, Poorrezagholi F, Firouzan A, Samadian F, Samavat S, Ziaie S, Fatemizadeh S. Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial. Trials. 2020 Jun 5;21(1):489. doi: 10.1186/s13063-020-04455-3.
- 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.
SBMU principal investigator
CKDRC,SBMU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine Tablets in people with COVID-19, run by Shahid Beheshti University of Medical Sciences at 2 sites in Iran.
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 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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.
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?
CRPxN/R ratio change (time frame: 2 weeks). The study lists 4 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 NCT04360980, 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 28 Jan 2022.