COVID-19Phase 2SILVERBULLETNCT04407507
Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms
A Phase 2 study testing Ivermectin in people with COVID-19, run by Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. at 1 site in Mexico.
Trial summary
This study aims to evaluate the efficacy, safety and tolerability of Ivermectin in patients with mild SARS-CoV-2 infection, in the rate of progression to severe 2019 novel coronavirus disease (COVID-19). 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?
- Ivermectin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2020to 29 Jan 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of acute severe respiratory syndrome due to SARS-CoV-12 coronavirus infection defined by RT-PCR.
- Asymptomatic, or with mild symptoms who are taking outpatient treatment of the disease.
- Signed Informed Consent.
Who cannot join
- Patients with severe disease COVID-19.
- Positive to proof of infection by some other virus such as influenza H1N1, SARS, etc.
- Recurrent urinary tract infections.
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)> 5 times above its normal limits.
- Pregnant or lactating patients
- Patients receiving antihypertensive medication verapamil, the immunosuppressant cyclosporin A and / or the antipsychotic trifluoperazine.
Show all 9Show fewer
- Patients with a known allergy or hypersensitivity to dewormers.
- Patients who are using an antioxidant supplement.
- Patients with a history of filariasis, strongyloidiasis, scabies, river blindness, or any parasitic disease in the last twelve months.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Investigacion Biomédica para el Desarrollo de Fármacos S.A. de C.V.
Zapopan, Jalisco
About this study
Official title: Multicenter, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of Ivermectin in Mild Virus-positive Subjects (SARS-CoV)-2 With or Without Symptoms
This study aims to evaluate the efficacy, safety and tolerability of Ivermectin in patients with mild SARS-CoV-2 infection, in the rate of progression to severe 2019 novel coronavirus disease (COVID-19).
The primary efficacy endpoint is the proportion of participants with a disease control status defined as no progression of severe disease Hypothesis (H0): There is no difference between group A (ivermectin + paracetamol) and group B (ivermectin + paracetamol) in terms of the primary endpoint on day 14.
Read the detailed description
In late 2019, an unidentified viral pneumonia was detected in Wuhan, China. Later, it was declared that it was pneumonia due to a new coronavirus. The World Health Organization (WHO) officially called it COVID-19 disease (Xie and Chen 2020).
Ivermectin is a broad-spectrum antiparasitic agent, developed to combat parasitic worms in veterinary use and in human medicine. This compound has been used orally in humans to treat filariasis, but is also effective against other worm-associated infections, as well as parasitic skin diseases and insect infections. It is approved for human use in several countries, to treat onchocerciasis, lymphatic filariasis, strongyloidiasis, and scabies, and recently in capillary pediculosis. When avermectins were discovered, they represented a new class of compounds that kill various ranges of disease-causing organisms, as well as pathogen vectors, inside and outside the body. Ivermectin is a semi-synthetic mixture of two chemically modified avermectins, comprising 80% 22,23-dihydroavermectin B1 and 20% 22,23-dihydroavermectin-B1b.
Other diseases that have been treated with ivermectin are: trichinosis, vector insects, malaria, trypanosomiasis, allergic asthma, rosacea, bedbugs, schistosomiasis, chagas disease, epilepsy, neurological diseases. Furthermore, it has been observed to have effects as an antibiotic and anticancer (Crump 2017).
In turn, Ivermectin has been described as a broad-spectrum antiviral, inhibiting nuclear import by its ability to inactivate host nuclear transport proteins, such as integrase and nonstructural protein 5 (NS5), limiting the ability to infect the western virus of the Nile in low concentrations (Yang et al. 2020), as well as inhibiting the replication of the yellow fever virus and other flaviviruses, such as dengue, and encephalitis, probably attacking the activity of nonstructural helicase 3 (Crump 2017).
Ivermectin, at a dose of 150-200 mcg / kg, is the first line of treatment for river blind disease (onchocerca volvulus), lymphatic filariasis, and strongyloidiasis(Crump 2017)..
French authorities approved ivermectin for humans in 1987. Shortly thereafter, Merck \& Co Inc donated ivermectin for onchocerciasis control. Since then, more than two billion treatments have been distributed in Africa and Latin America for onchocerciasis and lymphatic filariasis (Chaccour et al. 2013; Smit et al. 2016).
In this context, ivermectin adverse events have been mild, transient and associated with the intensity of the infection. No significant association was found between ivermectin plasma levels and adverse events(Merck \& Co 2009).
Wagstaff et al. published preliminary studies in in vitro cultures, where they observed that a 5000-fold reduction in the viral RNA content of cells infected with the SARS-CoV-2 virus, treated with a single dose of ivermectin (Caly et al. 2020).
Ivermectin therapy has not been tested in COVID-19 subjects and is therefore intended to be used as an adjuvant treatment; therefore, all study subjects will receive ivermectin or placebo in addition to therapy that their treating physician deems appropriate. Since ivermectin is in an early phase of clinical development, the use of base therapy will ensure that all subjects, including subjects who are randomized to receive placebo, have the benefit of receiving treatment with the base therapy that is available.
Research Objectives The main objective of this study is to evaluate the efficacy, safety and tolerability of ivermectin in patients with mild SARS-CoV-2 infection, in the rate of progression to severe COVID-19.
Secondary objectives
- Quantify the replication rate of the SARS-CoV-2 virus at days 5 and 14 after diagnosis quantitatively by real-time reverse transcription polymerase chain reaction (RT-PCR).
- Evaluate the presence and frequency of symptoms associated with COVID-19 disease (fever, cough, myalgia, fatigue, shortness of breath, headache, diarrhea, and expectoration) daily for 14 days.
- Investigate the presence of adverse events associated or not with the study drug for 14 days.
- Search for associations between the morbidities of the evaluated subjects and the intensity of the disease.
- Search for a relationship between medical history of bacille Calmette Guerin (BCG) vaccines and the intensity of the disease.
- Evaluate the frequency of death in the subjects, associated with COVID-19.
- Conditions
- COVID-19
- 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
ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
PlaceboDrug
Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days Receives: Drug: Ivermectin |
| Placebo | Placebo comparator | Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With a Disease Control Status Defined as no Disease Progression to Severe.
The subject is considered to have progressed to severe illness when one or more of the following criteria are present:
- Breathing difficulty (≥30 breaths per minute);
- Resting oxygen saturation ≤93%;
- Severe complications such as: respiratory failure, need for mechanical ventilation, septic shock, non-respiratory organic failure.
Measured: 14 days
Secondary outcomes (2)
SARS-CoV-2 Viral Load, at 5 and 14 Days
To determine viral load indirectly, the Ct value of the SARS-COV-2 gene N was used on days 1, 5 and 14 of treatment, considering values greater than 37.5 as negative.
Measured: days 1, 5 and 14
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Subjects were asked to answer a symptoms dairy during 14 days, where they recorded the presence of the following symptoms; fever, cough, muscular pain, fatigue, breath difficulty, headache, diarrhea, palpitations, expectoration and "Other", in the other question several subjects answer hypogeusia/ageusia, hyposmia/anosmia and backpain.
The total of days anaylized were considered as 100%; 364 days for placebo patients(26 subjects x 14 days), and 420 for ivermectin subjects (30 subjects x 14 days), then the number of days reported correspond to de % of days when symptom was present.
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 posted29 May 2020
- Study start1 Jul 2020
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alma M Perez, MD, Principal investigator, Centro de Investigación Farmacéutica Especializada de Occidente S.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407507
- Sponsor's protocol ID
- SARS-COV-IverMX-01
- Acronym
- SILVERBULLET
- Status last verified
- May 2021
- First submitted
- 27 May 2020
- Last updated
- 21 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Caly 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 32251768Chaccour CJ, Kobylinski KC, Bassat Q, Bousema T, Drakeley C, Alonso P, Foy BD. Ivermectin to reduce malaria transmission: a research agenda for a promising new tool for elimination. Malar J. 2013 May 7;12:153. doi: 10.1186/1475-2875-12-153.
PubMed 23647969Smit MR, Ochomo E, Aljayyoussi G, Kwambai T, Abong'o B, Bayoh N, Gimnig J, Samuels A, Desai M, Phillips-Howard PA, Kariuki S, Wang D, Ward S, Ter Kuile FO. Efficacy and Safety of High-Dose Ivermectin for Reducing Malaria Transmission (IVERMAL): Protocol for a Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Trial in Western Kenya. JMIR Res Protoc. 2016 Nov 17;5(4):e213. doi: 10.2196/resprot.6617.
PubMed 27856406Xie M, Chen Q. Insight into 2019 novel coronavirus - An updated interim review and lessons from SARS-CoV and MERS-CoV. Int J Infect Dis. 2020 May;94:119-124. doi: 10.1016/j.ijid.2020.03.071. Epub 2020 Apr 1.
PubMed 32247050Yang SNY, Atkinson SC, Wang C, Lee A, Bogoyevitch MA, Borg NA, Jans DA. The broad spectrum antiviral ivermectin targets the host nuclear transport importin alpha/beta1 heterodimer. Antiviral Res. 2020 May;177:104760. doi: 10.1016/j.antiviral.2020.104760. Epub 2020 Mar 3.
PubMed 32135219de la Rocha C, Cid-Lopez MA, Venegas-Lopez BI, Gomez-Mendez SC, Sanchez-Ortiz A, Perez-Rios AM, Llamas-Velazquez RA, Meza-Acuna AI, Vargas-Iniguez B, Rosales-Galvan D, Tavares-Valdez A, Luna-Gudino N, Hernandez-Puente CV, Milenkovic J, Iglesias-Palomares C, Mendez-Del Villar M, Gutierrez-Dieck GA, Valderrabano-Roldan CG, Mercado-Cerda J, Robles-Bojorquez JG, Mercado-Sesma AR. Ivermectin compared with placebo in the clinical course in Mexican patients with asymptomatic and mild COVID-19: a randomized clinical trial. BMC Infect Dis. 2022 Dec 8;22(1):917. doi: 10.1186/s12879-022-07890-6.
PubMed 36482326
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of Ivermectin in Mild Virus-positive Subjects (SARS-CoV)-2 With or Without Symptoms
- ClinicalTrials.gov ID
- NCT04407507
- Acronym / sponsor ID
- SILVERBULLET / SARS-COV-IverMX-01
- Conditions
- COVID-19
- Keywords
- Ivermectin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.University, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Posted 21 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy, safety and tolerability of Ivermectin in patients with mild SARS-CoV-2 infection, in the rate of progression to severe 2019 novel coronavirus disease (COVID-19).
The primary efficacy endpoint is the proportion of participants with a disease control status defined as no progression of severe disease Hypothesis (H0): There is no difference between group A (ivermectin + paracetamol) and group B (ivermectin + paracetamol) in terms of the primary endpoint on day 14.
Detailed description
In late 2019, an unidentified viral pneumonia was detected in Wuhan, China. Later, it was declared that it was pneumonia due to a new coronavirus. The World Health Organization (WHO) officially called it COVID-19 disease (Xie and Chen 2020).
Ivermectin is a broad-spectrum antiparasitic agent, developed to combat parasitic worms in veterinary use and in human medicine. This compound has been used orally in humans to treat filariasis, but is also effective against other worm-associated infections, as well as parasitic skin diseases and insect infections. It is approved for human use in several countries, to treat onchocerciasis, lymphatic filariasis, strongyloidiasis, and scabies, and recently in capillary pediculosis. When avermectins were discovered, they represented a new class of compounds that kill various ranges of disease-causing organisms, as well as pathogen vectors, inside and outside the body. Ivermectin is a semi-synthetic mixture of two chemically modified avermectins, comprising 80% 22,23-dihydroavermectin B1 and 20% 22,23-dihydroavermectin-B1b.
Other diseases that have been treated with ivermectin are: trichinosis, vector insects, malaria, trypanosomiasis, allergic asthma, rosacea, bedbugs, schistosomiasis, chagas disease, epilepsy, neurological diseases. Furthermore, it has been observed to have effects as an antibiotic and anticancer (Crump 2017).
In turn, Ivermectin has been described as a broad-spectrum antiviral, inhibiting nuclear import by its ability to inactivate host nuclear transport proteins, such as integrase and nonstructural protein 5 (NS5), limiting the ability to infect the western virus of the Nile in low concentrations (Yang et al. 2020), as well as inhibiting the replication of the yellow fever virus and other flaviviruses, such as dengue, and encephalitis, probably attacking the activity of nonstructural helicase 3 (Crump 2017).
Ivermectin, at a dose of 150-200 mcg / kg, is the first line of treatment for river blind disease (onchocerca volvulus), lymphatic filariasis, and strongyloidiasis(Crump 2017)..
French authorities approved ivermectin for humans in 1987. Shortly thereafter, Merck \& Co Inc donated ivermectin for onchocerciasis control. Since then, more than two billion treatments have been distributed in Africa and Latin America for onchocerciasis and lymphatic filariasis (Chaccour et al. 2013; Smit et al. 2016).
In this context, ivermectin adverse events have been mild, transient and associated with the intensity of the infection. No significant association was found between ivermectin plasma levels and adverse events(Merck \& Co 2009).
Wagstaff et al. published preliminary studies in in vitro cultures, where they observed that a 5000-fold reduction in the viral RNA content of cells infected with the SARS-CoV-2 virus, treated with a single dose of ivermectin (Caly et al. 2020).
Ivermectin therapy has not been tested in COVID-19 subjects and is therefore intended to be used as an adjuvant treatment; therefore, all study subjects will receive ivermectin or placebo in addition to therapy that their treating physician deems appropriate. Since ivermectin is in an early phase of clinical development, the use of base therapy will ensure that all subjects, including subjects who are randomized to receive placebo, have the benefit of receiving treatment with the base therapy that is available.
Research Objectives The main objective of this study is to evaluate the efficacy, safety and tolerability of ivermectin in patients with mild SARS-CoV-2 infection, in the rate of progression to severe COVID-19.
Secondary objectives
- Quantify the replication rate of the SARS-CoV-2 virus at days 5 and 14 after diagnosis quantitatively by real-time reverse transcription polymerase chain reaction (RT-PCR).
- Evaluate the presence and frequency of symptoms associated with COVID-19 disease (fever, cough, myalgia, fatigue, shortness of breath, headache, diarrhea, and expectoration) daily for 14 days.
- Investigate the presence of adverse events associated or not with the study drug for 14 days.
- Search for associations between the morbidities of the evaluated subjects and the intensity of the disease.
- Search for a relationship between medical history of bacille Calmette Guerin (BCG) vaccines and the intensity of the disease.
- Evaluate the frequency of death in the subjects, associated with COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin | Experimental | Drug: IvermectinIvermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboIvermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of acute severe respiratory syndrome due to SARS-CoV-12 coronavirus infection defined by RT-PCR.
- Asymptomatic, or with mild symptoms who are taking outpatient treatment of the disease.
- Signed Informed Consent.
Key exclusion criteria (9 listed)
- Patients with severe disease COVID-19.
- Positive to proof of infection by some other virus such as influenza H1N1, SARS, etc.
- Recurrent urinary tract infections.
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)> 5 times above its normal limits.
- Pregnant or lactating patients
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 |
|---|---|---|
| Ivermectinivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days | Drug | Ivermectin |
| PlaceboPlacebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days | Drug | Placebo |
Primary outcome
Participants With a Disease Control Status Defined as no Disease Progression to Severe.
Time frame: 14 days
The subject is considered to have progressed to severe illness when one or more of the following criteria are present: 1. Breathing difficulty (≥30 breaths per minute); 2. Resting oxygen saturation ≤93%; 3. Severe complications such as: respiratory failure, need for mechanical ventilation, septic shock, non-respiratory organic failure.
2 secondary outcomes
SARS-CoV-2 Viral Load, at 5 and 14 Days
Time frame: days 1, 5 and 14
Presence and Frequency of Symptoms Associated With the COVID-19 Disease
Time frame: 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: 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.
- Results publication: PubMed 23647969Chaccour CJ, Kobylinski KC, Bassat Q, Bousema T, Drakeley C, Alonso P, Foy BD. Ivermectin to reduce malaria transmission: a research agenda for a promising new tool for elimination. Malar J. 2013 May 7;12:153. doi: 10.1186/1475-2875-12-153.
- Results publication: PubMed 27856406Smit MR, Ochomo E, Aljayyoussi G, Kwambai T, Abong'o B, Bayoh N, Gimnig J, Samuels A, Desai M, Phillips-Howard PA, Kariuki S, Wang D, Ward S, Ter Kuile FO. Efficacy and Safety of High-Dose Ivermectin for Reducing Malaria Transmission (IVERMAL): Protocol for a Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Trial in Western Kenya. JMIR Res Protoc. 2016 Nov 17;5(4):e213. doi: 10.2196/resprot.6617.
- Results publication: PubMed 32247050Xie M, Chen Q. Insight into 2019 novel coronavirus - An updated interim review and lessons from SARS-CoV and MERS-CoV. Int J Infect Dis. 2020 May;94:119-124. doi: 10.1016/j.ijid.2020.03.071. Epub 2020 Apr 1.
- Results publication: PubMed 32135219Yang SNY, Atkinson SC, Wang C, Lee A, Bogoyevitch MA, Borg NA, Jans DA. The broad spectrum antiviral ivermectin targets the host nuclear transport importin alpha/beta1 heterodimer. Antiviral Res. 2020 May;177:104760. doi: 10.1016/j.antiviral.2020.104760. Epub 2020 Mar 3.
- Derived from this study: PubMed 36482326de la Rocha C, Cid-Lopez MA, Venegas-Lopez BI, Gomez-Mendez SC, Sanchez-Ortiz A, Perez-Rios AM, Llamas-Velazquez RA, Meza-Acuna AI, Vargas-Iniguez B, Rosales-Galvan D, Tavares-Valdez A, Luna-Gudino N, Hernandez-Puente CV, Milenkovic J, Iglesias-Palomares C, Mendez-Del Villar M, Gutierrez-Dieck GA, Valderrabano-Roldan CG, Mercado-Cerda J, Robles-Bojorquez JG, Mercado-Sesma AR. Ivermectin compared with placebo in the clinical course in Mexican patients with asymptomatic and mild COVID-19: a randomized clinical trial. BMC Infect Dis. 2022 Dec 8;22(1):917. doi: 10.1186/s12879-022-07890-6.
- Stromectol. FDA Approved Package Insert 2009Link provided by the sponsor.
Related trials for COVID-19
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.
Alma M Perez, MD principal investigator
Centro de Investigación Farmacéutica Especializada de Occidente S.C.
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 Ivermectin in people with COVID-19, run by Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. at 1 site in Mexico.
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 9 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 21 May 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 Mexico. 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?
Yes. Results are posted in the registry (first posted 21 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With a Disease Control Status Defined as no Disease Progression to Severe. (time frame: 14 days). 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 NCT04407507, which also lists 6 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 21 May 2021.