Coronavirus InfectionPhase 1/2SIZI-COVID-PKNCT04472585
Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients
A Phase 1/2 study testing Ivermectin Injectable Solution, Zinc and Oral Ivermectin in people with Coronavirus Infection and COVID, run by Sohaib Ashraf at 2 sites in Pakistan.
Trial summary
To measure the effect of Ivermectin (sub-cutaneous) with or without zinc 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 to 60 years
- Conditions the study is for
- Coronavirus Infection, COVID, Sars-CoV2
- What is being tested?
- Ivermectin Injectable Solution, Zinc and Oral Ivermectin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 2 sitesPakistan
- Study dates
- 14 Nov 2020to 30 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Nasopharyngeal RT-PCR positive SARS-CoV-2 patient with mild to moderate disease
- Age 18 and above
- BMI 18-28 kg/m
Who cannot join
- Allergy to any drug
- Co-morbidities: any pre-existing cardiac disease, pulmonary disease
- Arrhythmias
- Pregnancy
- RT-PCR performed >3 days prior to enrollment
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites, 2 recruiting
- Recruiting
Ali Clinic
Lahore, MA, 54600
Ahmad Imran, MBBS, +923334461038, ahmad.imran@skzmdc.edu.pk
- Recruiting
Shaikh Zayed Hospital
Lahore, Punjab Province, 54600
Sohaib Ashraf, MBBS, +923334474523, sohaib-ashraf@outlook.com
Muhammad Ahmad Imran, MBBS, +923338110708, ahmad.ammy93@gmail.com
About this study
Official title: Sub-cutaneous Ivermectin in Combination With and Without Oral Zinc: a Placebo Randomized Control Trial on Mild to Moderate COVID-19 Patients
To measure the effect of Ivermectin (sub-cutaneous) with or without zinc 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
This is a parallel assigned, randomized, controlled, multi-armed, investigator Initiated interventional study is designed to demonstrate efficacy to lower the viral load of COVID-19 and to demonstrate the antiviral effects of subcutaneous Ivermectin with or without zinc in mild to moderate symptomatic patients who consent to randomization following a new diagnosis in Pakistan with COVID-19 (PCR positive). Investigators will follow up with participants daily and PCR will be done on alternate days in BSL-3 lab. Dose will only be repeated if test remained positive..
- Conditions
- Coronavirus Infection, COVID, Sars-CoV2
- Being tested
- Ivermectin Injectable Solution, Injectable Placebo, Zinc, Placebo empty capsule, Oral Ivermectin
- Keywords
- SARS-Cov-2, COVID-19, Coronavirus, Ivermectin, Zinc
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin Injectable SolutionDrug
Also called Montpellier
Subcutaneous Ivermectin 200ug/kg body weight 48 hourly
Injectable PlaceboOther
Also called 0.9% normal saline
0.9% normal saline
ZincDrug
Zinc Sulphate 20mg 3 times a day
Placebo empty capsuleDrug
Placebo empty capsule
Oral IvermectinDrug
0.2mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin alone | Active comparator | Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care Receives: Drug: Ivermectin Injectable Solution; Drug: Placebo empty capsule |
| Ivermectin with Zinc | Active comparator | Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care Receives: Drug: Ivermectin Injectable Solution; Drug: Zinc; Drug: Placebo empty capsule |
| Placebo | Placebo comparator | Placebo drug plus standard care Receives: Other: Injectable Placebo; Drug: Placebo empty capsule |
| Ivermectin (oral) alone | Active comparator | Oral ivermectin 0.2mg/kg/day Receives: Drug: Placebo empty capsule; Drug: Oral Ivermectin |
| Ivermectin (oral) with Zinc | Active comparator | Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care Receives: Drug: Zinc; Drug: Placebo empty capsule; Drug: Oral Ivermectin |
| Zinc Alone | Active comparator | 20mg Zinc Sulphate 8 hourly plus standard care Receives: Drug: Zinc; Drug: Placebo empty capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
qRT-PCR
time needed to turn positive COVID-19 PCR to negative
Measured: 14 days
Time taken for alleviation of symptoms
time needed to turn off symptoms
Measured: upto 14 days
Severity of symptoms
time needed of symptom serverity
Measured: upto 14 days
Secondary outcomes (2)
Severity of symptoms
time needed to make patients clinically better
Measured: 14 days
Morality
death rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start14 Nov 2020
- Primary completion15 Aug 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronavirus 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled, multi-armed, open-label, interventional study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 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, Lahore, PakistanShoaib Ashraf, PhD, Study director, Harvard University Boston, USASohaib Ashraf, MBBS, Principal investigator, Shaikh Zayed Medical Complex, PakistanMoneeb Ashraf, MBBS, Principal investigator, Mayo Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472585
- Sponsor's protocol ID
- SZMC/IRB/Internal/215/2020
- Acronym
- SIZI-COVID-PK
- Status last verified
- Feb 2021
- First submitted
- 14 Jul 2020
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Simsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145.
PubMed 32293834Patri A, Fabbrocini G. Hydroxychloroquine and ivermectin: A synergistic combination for COVID-19 chemoprophylaxis and treatment? J Am Acad Dermatol. 2020 Jun;82(6):e221. doi: 10.1016/j.jaad.2020.04.017. Epub 2020 Apr 10. No abstract available.
PubMed 32283237Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
PubMed 32251768Ashraf S, Ashraf S, Farooq I, Ashraf S, Ashraf M, Imran MA, Kalsoom L, Akmal R, Ghufran M, Rafique S, Akram MK, Habib Z, Siddiqui UN, Ahmad A, Arshad S, Virk MAR, Gul M, Awais AB, Hassan M, Sherazi SSH, Safdar Z, Munir I, Khalid H, Munir K, Majeed N, Alahmadi YM, Humayun A, Saboor QA, Ahmad A, Ashraf M, Izhar M; DOCTORS LOUNGE Consortium. Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Sep 6;22(1):591. doi: 10.1186/s13063-021-05487-z.
PubMed 34488858
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sub-cutaneous Ivermectin in Combination With and Without Oral Zinc: a Placebo Randomized Control Trial on Mild to Moderate COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04472585
- Acronym / sponsor ID
- SIZI-COVID-PK / SZMC/IRB/Internal/215/2020
- Conditions
- Coronavirus Infection, COVID, Sars-CoV2
- Keywords
- SARS-Cov-2, COVID-19, Coronavirus, Ivermectin, Zinc
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sohaib AshrafUniversity, hospital or other
- Study start
- 14 Nov 2020 (actual)
- Primary completion
- 15 Aug 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 15 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.
To measure the effect of Ivermectin (sub-cutaneous) with or without zinc 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
This is a parallel assigned, randomized, controlled, multi-armed, investigator Initiated interventional study is designed to demonstrate efficacy to lower the viral load of COVID-19 and to demonstrate the antiviral effects of subcutaneous Ivermectin with or without zinc in mild to moderate symptomatic patients who consent to randomization following a new diagnosis in Pakistan with COVID-19 (PCR positive). Investigators will follow up with participants daily and PCR will be done on alternate days in BSL-3 lab. Dose will only be repeated if test remained positive..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- randomized, controlled, multi-armed, open-label, interventional study
| Arm | Type | Receives |
|---|---|---|
| Ivermectin alone | Active comparator | Drug: Ivermectin Injectable Solution, Drug: Placebo empty capsuleSub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care |
| Ivermectin with Zinc | Active comparator | Drug: Ivermectin Injectable Solution, Drug: Zinc, Drug: Placebo empty capsuleSub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care |
| Placebo | Placebo comparator | Other: Injectable Placebo, Drug: Placebo empty capsulePlacebo drug plus standard care |
| Ivermectin (oral) alone | Active comparator | Drug: Placebo empty capsule, Drug: Oral IvermectinOral ivermectin 0.2mg/kg/day |
| Ivermectin (oral) with Zinc | Active comparator | Drug: Zinc, Drug: Placebo empty capsule, Drug: Oral IvermectinOral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care |
| Zinc Alone | Active comparator | Drug: Zinc, Drug: Placebo empty capsule20mg Zinc Sulphate 8 hourly plus standard care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Nasopharyngeal RT-PCR positive SARS-CoV-2 patient with mild to moderate disease
- Age 18 and above
- BMI 18-28 kg/m
Key exclusion criteria (5 listed)
- Allergy to any drug
- Co-morbidities: any pre-existing cardiac disease, pulmonary disease
- Arrhythmias
- Pregnancy
- RT-PCR performed >3 days prior to enrollment
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 |
|---|---|---|
| Ivermectin Injectable SolutionAlso: MontpellierSubcutaneous Ivermectin 200ug/kg body weight 48 hourly | Drug | Ivermectin alone, Ivermectin with Zinc |
| Injectable PlaceboAlso: 0.9% normal saline0.9% normal saline | Other | Placebo |
| ZincZinc Sulphate 20mg 3 times a day | Drug | Ivermectin (oral) with Zinc, Ivermectin with Zinc, Zinc Alone |
| Placebo empty capsulePlacebo empty capsule | Drug | Ivermectin (oral) alone, Ivermectin (oral) with Zinc, Ivermectin alone, Ivermectin with Zinc, Placebo, Zinc Alone |
| Oral Ivermectin0.2mg/kg/day | Drug | Ivermectin (oral) alone, Ivermectin (oral) with Zinc |
Primary outcome
qRT-PCR
Time frame: 14 days
time needed to turn positive COVID-19 PCR to negative
Time taken for alleviation of symptoms
Time frame: upto 14 days
time needed to turn off symptoms
Severity of symptoms
Time frame: upto 14 days
time needed of symptom serverity
2 secondary outcomes
Severity of symptoms
Time frame: 14 days
Morality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Background: PubMed 32293834Simsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145.
- Background: PubMed 32283237Patri A, Fabbrocini G. Hydroxychloroquine and ivermectin: A synergistic combination for COVID-19 chemoprophylaxis and treatment? J Am Acad Dermatol. 2020 Jun;82(6):e221. doi: 10.1016/j.jaad.2020.04.017. Epub 2020 Apr 10. No abstract available.
- Background: PubMed 32251768Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
- Derived from this study: PubMed 34488858Ashraf S, Ashraf S, Farooq I, Ashraf S, Ashraf M, Imran MA, Kalsoom L, Akmal R, Ghufran M, Rafique S, Akram MK, Habib Z, Siddiqui UN, Ahmad A, Arshad S, Virk MAR, Gul M, Awais AB, Hassan M, Sherazi SSH, Safdar Z, Munir I, Khalid H, Munir K, Majeed N, Alahmadi YM, Humayun A, Saboor QA, Ahmad A, Ashraf M, Izhar M; DOCTORS LOUNGE Consortium. Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Sep 6;22(1):591. doi: 10.1186/s13063-021-05487-z.
- 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.
Muhammad Ashraf, PhD study chair
University of Veterinary & Animal Sciences, Lahore, Pakistan
Shoaib Ashraf, PhD study director
Harvard University Boston, USA
Sohaib Ashraf, MBBS principal investigator
Shaikh Zayed Medical Complex, Pakistan
2 sites 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 Ivermectin Injectable Solution, Zinc and Oral Ivermectin in people with Coronavirus Infection and COVID, run by Sohaib Ashraf at 2 sites 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 3 inclusion and 5 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 17 Feb 2021. 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 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 3 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 NCT04472585, which also lists 4 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 17 Feb 2021.