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Covid19Phase 2COVERNCT04438850

COVidIVERmectin: Ivermectin for Treatment of Covid-19

A Phase 2 study testing Ivermectin in people with Covid19, run by IRCCS Sacro Cuore Don Calabria di Negrar at 5 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Prospective, multi-centre, randomized, double-blind trial to assess efficacy and safety of ivermectin for the treatment of initial infection with SARS-CoV2 infection. Study arms: A) placebo B) ivermectin 600 μg/kg daily for 5 consecutive days (I_600) + placebo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Ivermectin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
93 participants
Where
5 sitesItaly
Study dates
31 Jul 2020to 8 Jun 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

  • Age >=18 years
  • Positivity at RT-PCR per SARS_CoV2 (nasopharyngeal swabs)
  • Consent to participation to the study and to the processing of personal data
  • COVID-19 Severity Score < 3
  • Patient able to take oral drugs

Who cannot join

  • Pregnant or lactating women (pregnancy test not required, if doubt patient is excluded)
  • Subjects suffering from known CNS diseases
  • Lack of (or inability to provide) informed consent
  • Patient under dialysis
  • Any severe medical condition with a prognosis of < 6 months
  • Patients under warfarin treatment
  • Patients under antiviral treatment
  • Patients under chloroquine phosphate or hydroxychloroquine

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Italy5 sites

  • Policlinico S. Orsola

    Bologna

  • Ospedale Luigi Sacco

    Milan

  • IRCCS Sacro Cuore Don Calabria hospital

    Negrar, Verona, 37024

  • Ospedale di Rovereto

    Rovereto

  • Ospedale Amedeo di Savoia

    Turin

Other trials in Italy

About this study

Official title: Randomized, Double-blind, Multi Centre Phase II, Proof of Concept, Dose Finding Clinical Trial on Ivermectin for the Early Treatment of COVID-19

Prospective, multi-centre, randomized, double-blind trial to assess efficacy and safety of ivermectin for the treatment of initial infection with SARS-CoV2 infection.

Study arms: A) placebo B) ivermectin 600 μg/kg daily for 5 consecutive days (I_600) + placebo. C) ivermectin 1200 μg/kg daily at empty stomach with water for 5 consecutive days (I_1200). Patients will be randomized at emergency room of hospitals as well as at outpatient ambulatory care as well as at home, according to routine procedures of recruiting centres.

In arm A and B, the number of placebo tablets to be administered will be calculated by the study dedicated pharmacist considering the number of tablets that should be taken in case a patient with the same weight is assigned to arm C.

Read the detailed description

Primary objectives

The study is aimed:

  1. at defining if ivermectin, administered at dosage of 600 μg/kg or 1200 μg/kg QD for five consecutive days is safe in patients with initial, asymptomatic or oligosymptomatic SARS_CoV-2 infection,
  2. at defining if ivermectin, administered at the dosage(s) found to be safe decreases the viral load of SARS-CoV-2 at Day 7.

Secondary objectives To assess

  1. the temporal profile of viral load at baseline, day 7, 14 and 30
  2. the time to clinical cure (for symptomatic patients)
  3. the proportion of patients with virological clearance at day 14 and 30.
  4. the hospitalization rate.
  5. the COVID-19 Severity Score at day 14 and 30

STUDY DESIGN

This is a multicentre, prospective, randomized, double-blind, adaptive phase II dose finding study.

Patients meeting the inclusion criteria will be asked to participate to the study and randomized in a 1:1:1 ratio to either:

  • Placebo arm (arm A): placebo will be identical in appearance to ivermectin in order to preserve blinding and will be administered p.o. at empty stomach with water once daily, for 5 days
  • Intervention arms: a) Ivermectin, single dose 600 μg/kg, for 5 days (I_600) and placebo (arm B) ; b) Ivermectin, single dose 1200 μg/kg, for 5 days (I_1200) (arm C) ); these drugs will be administered p.o. once daily, for 5 days.

In arm A and B, the number of placebo tablets to be administered will be calculated by the study dedicated pharmacist considering the number of tablets that should be taken in case a patient with the same weight is assigned to arm C.

Patients will be randomized by a centralized computer system. At randomization a treatment ID is assigned to the patient. Once a treatment ID is assigned this must not be re-assigned even in cases of errors.

Enrolled subjects will be identified by a unique subject number (patient code) that will remain consistent for the duration of the study.

Patients will be recruited at the emergency room of hospitals, and/or among asymptomatic hospital workers found positive for SARS-CoV-2 at routine screening and/or in outpatient ambulatory settings, and/or at home, if not meeting the clinical criteria for hospitalization, according to the routine procedure of each participating site. The expected duration of subject inclusion in the study is of 1 month, or until the planned number of subjects to be enrolled will be reached.

Conditions
Covid19
Being tested
Ivermectin, Placebo
Keywords
ivermectin
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IvermectinDrug

    Also called Ivermectin 9 mg cp by Chemo group

    Patients will be administered a single oral daily dose of approximately 600 μg/Kg (486-679 μg/Kg as rounded to a whole number of tablets), or 1200 μg/Kg (1098-1286 μg/Kg).

  • PlaceboOther

    Also called Placebo supplied by chemo group

    Patients should take placebo orally on an empty stomach with water

Study groups in NCT04438850
Study groupRoleWhat they receive
I_600Experimentalivermectin 600 μg/kg daily for 5 consecutive days (I_600) + placebo
Receives: Drug: Ivermectin
I_1200Experimentalivermectin 1200 μg/kg daily at empty stomach with water for 5 consecutive days
Receives: Drug: Ivermectin
PlaceboPlacebo comparatorplacebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SADR

    Number of serious adverse drug reaction

    Measured: 14 days

  2. Viral load

    Quantitative viral load as measured by quantitative, digital droplet PCR.

    Measured: Assessed at day 7

Secondary outcomes (6)

  1. Trend viral load

    1. Trend over time of quantitative viral load at Day 7 and 14 as measured by quantitative, digital droplet PCR.

    Measured: Days 7 and 14 from baseline

  2. Clinical resolution

    Time to clinical resolution (for symptomatic patients).

    Measured: Assessed on Day 30

  3. Viral clearance

    Time from diagnosis to documented viral clearance

    Measured: assessed on days 14 and 30

  4. Virological clearance

    Proportion of patients with virological clearance

    Measured: Assessed at day 14 and 30

  5. hospitalization rate

    rate of hospitalization

    Measured: Day 30

  6. Severity score

    COVID-19 Severity Score (Coronavirus Diseases 19 Severity Score) - min value 1 ("no limitation of activities), max value 8 ("death"). Higher scores mean worse outcome

    Measured: Assessed at Day 14 and Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2020
  2. Study start31 Jul 2020
  3. Primary completion8 Jun 2021
  4. Study completion8 Jun 2021

Why it stopped: Incidence has dramatically dropped and there is lack of eligible patients

Resources

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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04438850
Sponsor's protocol ID
cover_1
Acronym
COVER
Status last verified
Jun 2021
First submitted
10 Apr 2020
Last updated
23 Jun 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The anonymized database will be uploaded into a public repository

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ivermectin in people with Covid19, run by IRCCS Sacro Cuore Don Calabria di Negrar at 5 sites in Italy.

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 5 inclusion and 8 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: stopped early, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. 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 was stopped early (reason given: Incidence has dramatically dropped and there is lack of eligible patients). Results are not available in the source record.

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?

SADR (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 NCT04438850.

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 23 Jun 2021.

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