Covid19Phase 1/2I-COVID-PKNCT04473261
Efficacy of Iodine Complex Against COVID-19 Patients
A Phase 1/2 study testing Iodine Complex and Idoine Complex in people with Covid19 and SARS-CoV-2, run by Sohaib Ashraf at 1 site in Pakistan.
Trial summary
The objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV-2, Corona Virus Infection
- What is being tested?
- Iodine Complex and Idoine Complex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Jul 2020to 15 Oct 2021
- Phase
- Phase 1/2
- 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
- Positive PCR with mild to moderate disease
Who cannot join
- Allergic to iodine
- Any co-morbidity other than hypertension and dietetics
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Shaikh Zayed Hospital
Lahore, 54600
Sohaib Ashraf, MBBS, +923334474523, sohaib@skzmdc.edu.pk
Muhammad Ahmad Imran, MBBS, +923338110708, ahmad.ammy93@gmail.com
About this study
Official title: Efficacy of Iodine Complex in Mild to Moderate COVID-19 Patients
The objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.
Read the detailed description
The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation ratio and superiority framework.
- Conditions
- Covid19, SARS-CoV-2, Corona Virus Infection
- Being tested
- Iodine Complex, Placebo, Idoine Complex
- Keywords
- SARS-Cov-2, COVID-19, Coronavirus, Iodine Complex
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine ComplexDrug
Iodine Complex capsule (200mg) will be given three times a day
Iodine ComplexDrug
Iodine Complex syrup form (40ml) will be given three times a day
PlaceboDrug
Also called capsule
Empty capsule will be given as placebo
Idoine ComplexDrug
Iodine Complex spray form 2 puffs will be given three times a day
| Study group | Role | What they receive |
|---|---|---|
| Iodine Complex (Capsule form) | Experimental | Iodine Complex) capsule (200mg) will be given three times a day Receives: Drug: Iodine Complex |
| Iodine Complex (Syrup form) | Experimental | Iodine Complex syrup form (40ml) will be given three times a day Receives: Drug: Iodine Complex |
| Standard Care Alone | Placebo comparator | Placebo as empty capsule. Treatment will be given for all 4 arms will be receiving standard care as per version 3.0 of clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan COVID-19 guidelines of the study setting. Receives: Drug: Placebo |
| Iodine Complex (Nasal Spray) | Experimental | Iodine complex throat spray of 2 puffs three times a day. Receives: Drug: Idoine Complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
qRT-PCR
Time taken for viral load clearance
Measured: 14 days
HRCT chest
Time taken for radiological improvement
Measured: 14 days
Secondary outcomes (1)
Severity of Symptoms
Time taken for symptomatic response in patients
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start14 Jul 2020
- Primary completion15 Aug 2021 (estimated)
- Study completion15 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, multi-armed, close-label, interventional study designed
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohaib Ashraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute
- Investigators
- Muhammad Ashraf, PhD, Study chair, University of Veterinary & Animal Sciences, PakistanShoaib Ashraf, PhD, Study director, Harvard University, Massachusetts General Hospital, Boston, USAMoneeb Ashraf, MBBS, Principal investigator, Mayo Hospital, PakistanSohaib Ashraf, MBBS, Principal investigator, Shaikh Zayed Medical Complex, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473261
- Sponsor's protocol ID
- SZMC/IRB/Internal/216/2020
- Acronym
- I-COVID-PK
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ashraf S, Ashraf S, Ashraf M, Farooq I, Akmal R, Imran MA, Kalsoom L, Ashraf S, Rafique S, Ghufran M, Akram MK, Sohaib-Ur-Rehman, Nadeem MF, Matti N, Siddiqui UN, Humayun A, Saboor QA, Ahmad A, Ashraf M, Izhar M; DOCTORS LOUNGE consortium. Clinical efficacy of iodine complex in SARS-CoV-2-infected patients with mild to moderate symptoms: study protocol for a randomized controlled trial. Trials. 2022 Jan 19;23(1):58. doi: 10.1186/s13063-021-05848-8.
PubMed 35045888Ashraf S, Ashraf S, Ashraf M, Imran MA, Kalsoom L, Siddiqui UN, Farooq I, Ghufran M, Khokhar RA, Akram MK, Shahid I, Sohaib Ur Rehman M, Akmal R, Tahir A, Zahid A, Ashraf S, Rafique S, Matti N, Nadeem MF, Humayun A, Malik A, Saboor QA, Ahmad A, Ashraf M, Izhar M. A quadruple blinded placebo controlled randomised trial to evaluate the effectiveness of an Iodine complex for patients with mild to moderate COVID-19 in Pakistan (I-COVID-PK): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Feb 10;22(1):127. doi: 10.1186/s13063-021-05081-3.
PubMed 33568226
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Iodine Complex in Mild to Moderate COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04473261
- Acronym / sponsor ID
- I-COVID-PK / SZMC/IRB/Internal/216/2020
- Conditions
- Covid19, SARS-CoV-2, Corona Virus Infection
- Keywords
- SARS-Cov-2, COVID-19, Coronavirus, Iodine Complex
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohaib AshrafUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 15 Aug 2021 (estimated)
- Study completion
- 15 Oct 2021 (estimated)
- First posted
- 16 Jul 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.
The objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.
Detailed description
The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation ratio and superiority framework.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, controlled, multi-armed, close-label, interventional study designed
| Arm | Type | Receives |
|---|---|---|
| Iodine Complex (Capsule form) | Experimental | Drug: Iodine ComplexIodine Complex) capsule (200mg) will be given three times a day |
| Iodine Complex (Syrup form) | Experimental | Drug: Iodine ComplexIodine Complex syrup form (40ml) will be given three times a day |
| Standard Care Alone | Placebo comparator | Drug: PlaceboPlacebo as empty capsule. Treatment will be given for all 4 arms will be receiving standard care as per version 3.0 of clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan COVID-19 guidelines of the study setting. |
| Iodine Complex (Nasal Spray) | Experimental | Drug: Idoine ComplexIodine complex throat spray of 2 puffs three times a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Positive PCR with mild to moderate disease
Key exclusion criteria (2 listed)
- Allergic to iodine
- Any co-morbidity other than hypertension and dietetics
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 |
|---|---|---|
| Iodine ComplexIodine Complex capsule (200mg) will be given three times a day | Drug | Iodine Complex (Capsule form) |
| Iodine ComplexIodine Complex syrup form (40ml) will be given three times a day | Drug | Iodine Complex (Syrup form) |
| PlaceboAlso: capsuleEmpty capsule will be given as placebo | Drug | Standard Care Alone |
| Idoine ComplexIodine Complex spray form 2 puffs will be given three times a day | Drug | Iodine Complex (Nasal Spray) |
Primary outcome
qRT-PCR
Time frame: 14 days
Time taken for viral load clearance
HRCT chest
Time frame: 14 days
Time taken for radiological improvement
1 secondary outcome
Severity of Symptoms
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Derived from this study: PubMed 35045888Ashraf S, Ashraf S, Ashraf M, Farooq I, Akmal R, Imran MA, Kalsoom L, Ashraf S, Rafique S, Ghufran M, Akram MK, Sohaib-Ur-Rehman, Nadeem MF, Matti N, Siddiqui UN, Humayun A, Saboor QA, Ahmad A, Ashraf M, Izhar M; DOCTORS LOUNGE consortium. Clinical efficacy of iodine complex in SARS-CoV-2-infected patients with mild to moderate symptoms: study protocol for a randomized controlled trial. Trials. 2022 Jan 19;23(1):58. doi: 10.1186/s13063-021-05848-8.
- Derived from this study: PubMed 33568226Ashraf S, Ashraf S, Ashraf M, Imran MA, Kalsoom L, Siddiqui UN, Farooq I, Ghufran M, Khokhar RA, Akram MK, Shahid I, Sohaib Ur Rehman M, Akmal R, Tahir A, Zahid A, Ashraf S, Rafique S, Matti N, Nadeem MF, Humayun A, Malik A, Saboor QA, Ahmad A, Ashraf M, Izhar M. A quadruple blinded placebo controlled randomised trial to evaluate the effectiveness of an Iodine complex for patients with mild to moderate COVID-19 in Pakistan (I-COVID-PK): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Feb 10;22(1):127. doi: 10.1186/s13063-021-05081-3.
- Individual participant dataSharing planned: Undecided
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Muhammad Ashraf, PhD study chair
University of Veterinary & Animal Sciences, Pakistan
Shoaib Ashraf, PhD study director
Harvard University, Massachusetts General Hospital, Boston, USA
Moneeb Ashraf, MBBS principal investigator
Mayo Hospital, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Iodine Complex and Idoine Complex in people with Covid19 and SARS-CoV-2, run by Sohaib Ashraf at 1 site in Pakistan.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Jul 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 Pakistan. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohaib Ashraf, MBBS (+923334474523, sohaib-ashraf@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
qRT-PCR (time frame: 14 days). The study lists 2 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 NCT04473261, which also lists 2 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 Jul 2021.