Covid19Phase 3NCT04673214
Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment
A Phase 3 study testing Azithromycin / Ivermectin / Ribaroxaban / Paracetamol and Azithromycin / Ribaroxaban / Paracetamol in people with Covid19, run by Gilberto Cruz Arteaga at 1 site in Mexico.
Trial summary
The present study is designed for patients with mild COVID-19 phase, to demonstrate if there is a modification in the clinical evolution greater than or equal to 25% in their symptoms, implemented in two groups of patients under an early intervention treatment, a group ( A) will receive Azithromycin / Ivermectin /… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Azithromycin / Ivermectin / Ribaroxaban / Paracetamol and Azithromycin / Ribaroxaban / Paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteMexico
- Study dates
- 16 Dec 2020to 25 Feb 2021
- Phase
- Phase 3
- 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
- Patients Eligible for Family Medicine Unit No.20 and Family Medicine Unit No.13 belonging to the North DF of the IMSS.
- Male and female patients
- Patients over 18 years of age.
- Patients with compliance with the operational definition COVID-19 and confirmatory test of P.C.R. positive within the first days of the illness (that are evaluated in first level of medical attention).
- Patients with comorbidities such as Type 2 Diabetes Mellitus, Systemic Arterial Hypertension, Overweight or Obesity.
- That they agree to sign an informed consent
- Related to Video Call:
- That the Family Medicine Unit No.20 and the Family Medicine Unit No.13 belonging to the North DF of the IMSS have the Installation of Electronic Equipment for Internet use
Who cannot join
- Severe COVID-19 patients (Ameriten sent immediately to second level of care, hospital) Patients with any Personal Pathological History of Hematological Diseases. • Patients allergic to macrolides (Azithromycin) and Ivermectin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Modification in Patients With COVID-19 Under Early Intervention Treatment at U.M.F 13 and U.M.F 20
The present study is designed for patients with mild COVID-19 phase, to demonstrate if there is a modification in the clinical evolution greater than or equal to 25% in their symptoms, implemented in two groups of patients under an early intervention treatment, a group ( A) will receive Azithromycin / Ivermectin / Ribaroxaban / Paracetamol and another group (B) will receive Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call
Read the detailed description
Coronavirus disease (COVID-19) is caused by SARS-COV2 and represents the causative agent of a potential fatal disease generating a global public health problem. Person-to-person transmission of COVID-19 infection led to the isolation of patients who subsequently received a variety of treatments. Ivermectin treatment for safety is approved for human use by the FDA in parasitic and skin infections. Studies report the therapeutic safety of Ivermectin in humans with COVID-19, describing a 6.1-fold decrease in lethality compared to patients who did not use Ivermectin (1.4 vs. 8.5%, p <0.0001). In this sense, the WHO and PAHO encourage the use of unproven therapies in the context of a randomized clinical trial (RCT). Anticoagulants have reported up to 20% in the reduction of mortality (heparin), Ribaroxaban is effective with the inhibition of PAR1 / PAR2 / PAR4 receptors through the blocking of Factor Xa and the formation of thrombin, having anti-inflammatory effects, decreasing arteriosclerosis and platelet aggregation. There is a Telemedicine working method implemented by the OOAD of the North Federal District, which detects early signs and symptoms of possible complications and offers an early intervention treatment policy for first-level care beneficiaries. Under this method, a quasi-experimental study showed that there is a modification in the frequency of recovered patients of 80-90% in patients diagnosed with COVID-19 after an early intervention treatment with paracetamol, Ivermectin, Azithromycin, Ribaroxaban in patients with COVID -19 from UMF 13 during the period of July-August 2020. Therefore, it is necessary to carry out a randomized clinical trial to confirm this assertion.
Objective: To evaluate the percentage of patients with a diagnosis of COVID-19 who modify their clinical evolution under a comparative treatment of early intervention in beneficiaries of the U.M.F 13 and U.M.F 20 of the I.M.S.S., during the period of December 2020-January 2021.
Material and Methods: A randomized, single-blind, prospective, longitudinal and open experimental study in 62 patients with COVID-19 from UMF No. 13 and No. 20 from November to December 2020. Including 31 patients in group A (Azithromycin / Ivermectin / Ribaroxaban / Paracetamol) and 31 patients in group B (Azithromycin / Ribaroxaban / Paracetamol). With inclusion criteria over 18 years of age, have type 2 diabetes mellitus, Systemic Arterial Hypertension, Obesity or overweight, PCR confirmation of COVID-19. For the video call, the Family Medicine Units have Electronic Equipment Installation for Internet use. Exclusion criteria are patients with severe COVID-19 (they deserve immediate referral to second level of care, hospital). Elimination criteria are Prior informed consent, medication is given randomly to a COVID-19 patient, a follow-up video call will be made at home for 14 days, recording sex, age, education, date of disease onset, taking laboratories (hematic biometry, C-reactive protein, D-dimer, Ferritin, prothrombin time, thromboplastin time, lactic dehydrogenase) taken at the onset of the disease, taking as an outcome variable the modification of the clinical course (clinical symptoms such as headache, cough, fever, conjunctivitis , myalgias, arthralgias, rhinorrhea, odynophagia, anosmia, chest pain, dyspnea) when granting treatment in groups A and B.. Statistical differences will be evaluated using the Mann-Whitney U test with a power of 90% and a type I error rate of 1% for the variable of modification of the clinical course in treatment groups A and B. analysis will be performed in SPSS version 21.
- Conditions
- Covid19
- Being tested
- Azithromycin / Ivermectin / Ribaroxaban / Paracetamol, Azithromycin / Ribaroxaban / Paracetamol
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin / Ivermectin / Ribaroxaban / ParacetamolDrug
Also called with Ivermectin
In the patient with the presence of COVID-19 confirmed by the PCR-COVID-19 positive test, the drug is randomly assigned to belong to group A of Azithromycin / Ivermectin / Ribaroxaban / Paracetamol to be followed for 14 days by video call (approximately 15 to 20 min per day) to the patient and the presence or absence of clinical symptoms, adverse reactions being recorded daily
Azithromycin / Ribaroxaban / ParacetamolDrug
Also called without Ivermectin
In the patient with the presence of COVID-19 confirmed by the PCR-COVID-19 positive test, the drug is randomly assigned to belong to group B of Azithromycin / Ribaroxaban / Paracetamol, to be followed for 14 days by video call (approximately 15 to 20 min per day) to the patient and the presence or absence of clinical symptoms, adverse reactions being recorded daily
| Study group | Role | What they receive |
|---|---|---|
| Triple therapy | Experimental | Paracetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C, Azithromycin 500 mg tablets will take 1 tablet single dose the first day and then half tablet (250 mg) orally every 24 for 4 days, Ivermectin tablets of 200mcg which will be calculated according to your weight and dose, will be every 24 hours for 2 days and Rivaroxaban tablets of 10 mg will take 1 every 24 hours for 10 days Receives: Drug: Azithromycin / Ivermectin / Ribaroxaban / Paracetamol |
| Double therapy | Active comparator | Paracetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C, Azithromycin 500 mg tablets will take 1 tablet single dose the first day and then half a tablet orally every 24 for 4 days and Rivaroxaban 10 mg tablets will take 1 every 24 hours for 10 days. Receives: Drug: Azithromycin / Ribaroxaban / Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Statistical differences were evaluated using Student's t test for quantitative variables. In relation to the presence of the number of days with clinical symptoms of COVID-19 by double therapy vs. triple therapy.
Measured: 14 days
Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS
Statistical differences between clinical evolution vs therapeutic failure by type of treatment were evaluated using Pearson's Chi-square test as categorical variables.
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 posted17 Dec 2020
- Study start16 Dec 2020
- Primary completion25 Feb 2021
- Study completion25 Feb 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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of patients with COVID-19 will be integrated, a Group A taking the following medications: Paracetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C, Azithromycin tablets of 500 mg will take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days, Ivermectin tablets of 200mcg which will be calculated according to your weight and dose, it will be every 24 hours for 2 days and Rivaroxaban 10 mg tablets will take 1 every 24 hours for 10 days and a Group B will take Paracetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C, Azithromycin tablets of 500 mg will take 1 single dose tablet on the first day and then half a tablet orally every 24 hours for 4 days and Rivaroxaban 10 mg tablets will take 1 every 24 hours for 10 days.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilberto Cruz Arteaga
- Sponsor type
- Other government
- Collaborators
- Coordinación de Investigación en Salud, Mexico
- Responsible party
- Sponsor-investigator, Gilberto Cruz Arteaga, Coordinación de Investigación en Salud, Mexico
- Investigators
- GILBERTO CR ARTEAGA, specialist, Principal investigator, MEXICAN SOCIAL SECURITY INSTITUTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673214
- Sponsor's protocol ID
- R-2020-785-176
- Status last verified
- Aug 2021
- First submitted
- 16 Dec 2020
- Last updated
- 16 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: SHARED VIA EMAIL IF OTHER RESEARCHERS REQUIRE IT
Publications
Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.
PubMed 32205204Becattini C, Pace U, Rondelli F, Delrio P, Ceccarelli G, Boncompagni M, Graziosi L, Visona A, Chiari D, Avruscio G, Frasson S, Gussoni G, Biancafarina A, Camporese G, Donini A, Bucci AF, Agnelli G. Rivaroxaban for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer. Design of the PRO-LAPS II STUDY. Eur J Intern Med. 2020 Feb;72:53-59. doi: 10.1016/j.ejim.2019.11.015. Epub 2019 Dec 7.
PubMed 31818628Khorana AA, Soff GA, Kakkar AK, Vadhan-Raj S, Riess H, Wun T, Streiff MB, Garcia DA, Liebman HA, Belani CP, O'Reilly EM, Patel JN, Yimer HA, Wildgoose P, Burton P, Vijapurkar U, Kaul S, Eikelboom J, McBane R, Bauer KA, Kuderer NM, Lyman GH; CASSINI Investigators. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. doi: 10.1056/NEJMoa1814630.
PubMed 30786186Dugina TN, Kiseleva EV, Chistov IV, Umarova BA, Strukova SM. Receptors of the PAR family as a link between blood coagulation and inflammation. Biochemistry (Mosc). 2002 Jan;67(1):65-74. doi: 10.1023/a:1013952114485.
PubMed 11841341Choudhary R, Sharma AK. Potential use of hydroxychloroquine, ivermectin and azithromycin drugs in fighting COVID-19: trends, scope and relevance. New Microbes New Infect. 2020 Apr 22;35:100684. doi: 10.1016/j.nmni.2020.100684. eCollection 2020 May.
PubMed 32322397Arshad U, Pertinez H, Box H, Tatham L, Rajoli RKR, Curley P, Neary M, Sharp J, Liptrott NJ, Valentijn A, David C, Rannard SP, O'Neill PM, Aljayyoussi G, Pennington SH, Ward SA, Hill A, Back DJ, Khoo SH, Bray PG, Biagini GA, Owen A. Prioritization of Anti-SARS-Cov-2 Drug Repurposing Opportunities Based on Plasma and Target Site Concentrations Derived from their Established Human Pharmacokinetics. Clin Pharmacol Ther. 2020 Oct;108(4):775-790. doi: 10.1002/cpt.1909. Epub 2020 Jun 14.
PubMed 32438446
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Modification in Patients With COVID-19 Under Early Intervention Treatment at U.M.F 13 and U.M.F 20
- ClinicalTrials.gov ID
- NCT04673214
- Acronym / sponsor ID
- R-2020-785-176
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Gilberto Cruz ArteagaOther government
- Collaborators
- Coordinación de Investigación en Salud, Mexico
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Posted 16 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is designed for patients with mild COVID-19 phase, to demonstrate if there is a modification in the clinical evolution greater than or equal to 25% in their symptoms, implemented in two groups of patients under an early intervention treatment, a group ( A) will receive Azithromycin / Ivermectin / Ribaroxaban / Paracetamol and another group (B) will receive Azithromycin / Ribaroxaban / Paracetamol followed for 14 days followed by video call
Detailed description
Coronavirus disease (COVID-19) is caused by SARS-COV2 and represents the causative agent of a potential fatal disease generating a global public health problem. Person-to-person transmission of COVID-19 infection led to the isolation of patients who subsequently received a variety of treatments. Ivermectin treatment for safety is approved for human use by the FDA in parasitic and skin infections. Studies report the therapeutic safety of Ivermectin in humans with COVID-19, describing a 6.1-fold decrease in lethality compared to patients who did not use Ivermectin (1.4 vs. 8.5%, p <0.0001). In this sense, the WHO and PAHO encourage the use of unproven therapies in the context of a randomized clinical trial (RCT). Anticoagulants have reported up to 20% in the reduction of mortality (heparin), Ribaroxaban is effective with the inhibition of PAR1 / PAR2 / PAR4 receptors through the blocking of Factor Xa and the formation of thrombin, having anti-inflammatory effects, decreasing arteriosclerosis and platelet aggregation. There is a Telemedicine working method implemented by the OOAD of the North Federal District, which detects early signs and symptoms of possible complications and offers an early intervention treatment policy for first-level care beneficiaries. Under this method, a quasi-experimental study showed that there is a modification in the frequency of recovered patients of 80-90% in patients diagnosed with COVID-19 after an early intervention treatment with paracetamol, Ivermectin, Azithromycin, Ribaroxaban in patients with COVID -19 from UMF 13 during the period of July-August 2020. Therefore, it is necessary to carry out a randomized clinical trial to confirm this assertion.
Objective: To evaluate the percentage of patients with a diagnosis of COVID-19 who modify their clinical evolution under a comparative treatment of early intervention in beneficiaries of the U.M.F 13 and U.M.F 20 of the I.M.S.S., during the period of December 2020-January 2021.
Material and Methods: A randomized, single-blind, prospective, longitudinal and open experimental study in 62 patients with COVID-19 from UMF No. 13 and No. 20 from November to December 2020. Including 31 patients in group A (Azithromycin / Ivermectin / Ribaroxaban / Paracetamol) and 31 patients in group B (Azithromycin / Ribaroxaban / Paracetamol). With inclusion criteria over 18 years of age, have type 2 diabetes mellitus, Systemic Arterial Hypertension, Obesity or overweight, PCR confirmation of COVID-19. For the video call, the Family Medicine Units have Electronic Equipment Installation for Internet use. Exclusion criteria are patients with severe COVID-19 (they deserve immediate referral to second level of care, hospital). Elimination criteria are Prior informed consent, medication is given randomly to a COVID-19 patient, a follow-up video call will be made at home for 14 days, recording sex, age, education, date of disease onset, taking laboratories (hematic biometry, C-reactive protein, D-dimer, Ferritin, prothrombin time, thromboplastin time, lactic dehydrogenase) taken at the onset of the disease, taking as an outcome variable the modification of the clinical course (clinical symptoms such as headache, cough, fever, conjunctivitis , myalgias, arthralgias, rhinorrhea, odynophagia, anosmia, chest pain, dyspnea) when granting treatment in groups A and B.. Statistical differences will be evaluated using the Mann-Whitney U test with a power of 90% and a type I error rate of 1% for the variable of modification of the clinical course in treatment groups A and B. analysis will be performed in SPSS version 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups of patients with COVID-19 will be integrated, a Group A taking the following medications: Paracetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C, Azithromycin tablets of 500 mg will take 1 single dose tablet the first day and then half a tablet (250 mg) orally every 24 for 4 days, Ivermectin tablets of 200mcg which will be calculated according to your weight and dose, it will be every 24 hours for 2 days and Rivaroxaban 10 mg tablets will take 1 every 24 hours for 10 days and a Group B will take Paracetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C, Azithromycin tablets of 500 mg will take 1 single dose tablet on the first day and then half a tablet orally every 24 hours for 4 days and Rivaroxaban 10 mg tablets will take 1 every 24 hours for 10 days.
| Arm | Type | Receives |
|---|---|---|
| Triple therapy | Experimental | Drug: Azithromycin / Ivermectin / Ribaroxaban / ParacetamolParacetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C, Azithromycin 500 mg tablets will take 1 tablet single dose the first day and then half tablet (250 mg) orally every 24 for 4 days, Ivermectin tablets of 200mcg which will be calculated according to your weight and dose, will be every 24 hours for 2 days and Rivaroxaban tablets of 10 mg will take 1 every 24 hours for 10 days |
| Double therapy | Active comparator | Drug: Azithromycin / Ribaroxaban / ParacetamolParacetamol 500 mg orally 1 tablet every 8 hours for 3 days in case of fever equal to or greater than 38.3 ° C, Azithromycin 500 mg tablets will take 1 tablet single dose the first day and then half a tablet orally every 24 for 4 days and Rivaroxaban 10 mg tablets will take 1 every 24 hours for 10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients Eligible for Family Medicine Unit No.20 and Family Medicine Unit No.13 belonging to the North DF of the IMSS.
- Male and female patients
- Patients over 18 years of age.
- Patients with compliance with the operational definition COVID-19 and confirmatory test of P.C.R. positive within the first days of the illness (that are evaluated in first level of medical attention).
- Patients with comorbidities such as Type 2 Diabetes Mellitus, Systemic Arterial Hypertension, Overweight or Obesity.
Key exclusion criteria (1 listed)
- Severe COVID-19 patients (Ameriten sent immediately to second level of care, hospital) Patients with any Personal Pathological History of Hematological Diseases. • Patients allergic to macrolides (Azithromycin) and Ivermectin.
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 |
|---|---|---|
| Azithromycin / Ivermectin / Ribaroxaban / ParacetamolAlso: with IvermectinIn the patient with the presence of COVID-19 confirmed by the PCR-COVID-19 positive test, the drug is randomly assigned to belong to group A of Azithromycin / Ivermectin / Ribaroxaban / Paracetamol to be followed for 14 days by video call (approximately 15 to 20 min per day) to the patient and the presence or absence of clinical symptoms, adverse reactions being recorded daily | Drug | Triple therapy |
| Azithromycin / Ribaroxaban / ParacetamolAlso: without IvermectinIn the patient with the presence of COVID-19 confirmed by the PCR-COVID-19 positive test, the drug is randomly assigned to belong to group B of Azithromycin / Ribaroxaban / Paracetamol, to be followed for 14 days by video call (approximately 15 to 20 min per day) to the patient and the presence or absence of clinical symptoms, adverse reactions being recorded daily | Drug | Double therapy |
Primary outcome
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.
Time frame: 14 days
Statistical differences were evaluated using Student's t test for quantitative variables. In relation to the presence of the number of days with clinical symptoms of COVID-19 by double therapy vs. triple therapy.
Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS
Time frame: 14 days
Statistical differences between clinical evolution vs therapeutic failure by type of treatment were evaluated using Pearson's Chi-square test as categorical variables.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32205204Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.
- Background: PubMed 31818628Becattini C, Pace U, Rondelli F, Delrio P, Ceccarelli G, Boncompagni M, Graziosi L, Visona A, Chiari D, Avruscio G, Frasson S, Gussoni G, Biancafarina A, Camporese G, Donini A, Bucci AF, Agnelli G. Rivaroxaban for extended antithrombotic prophylaxis after laparoscopic surgery for colorectal cancer. Design of the PRO-LAPS II STUDY. Eur J Intern Med. 2020 Feb;72:53-59. doi: 10.1016/j.ejim.2019.11.015. Epub 2019 Dec 7.
- Background: PubMed 30786186Khorana AA, Soff GA, Kakkar AK, Vadhan-Raj S, Riess H, Wun T, Streiff MB, Garcia DA, Liebman HA, Belani CP, O'Reilly EM, Patel JN, Yimer HA, Wildgoose P, Burton P, Vijapurkar U, Kaul S, Eikelboom J, McBane R, Bauer KA, Kuderer NM, Lyman GH; CASSINI Investigators. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. doi: 10.1056/NEJMoa1814630.
- Background: PubMed 11841341Dugina TN, Kiseleva EV, Chistov IV, Umarova BA, Strukova SM. Receptors of the PAR family as a link between blood coagulation and inflammation. Biochemistry (Mosc). 2002 Jan;67(1):65-74. doi: 10.1023/a:1013952114485.
- Background: PubMed 32322397Choudhary R, Sharma AK. Potential use of hydroxychloroquine, ivermectin and azithromycin drugs in fighting COVID-19: trends, scope and relevance. New Microbes New Infect. 2020 Apr 22;35:100684. doi: 10.1016/j.nmni.2020.100684. eCollection 2020 May.
- Background: PubMed 32438446Arshad U, Pertinez H, Box H, Tatham L, Rajoli RKR, Curley P, Neary M, Sharp J, Liptrott NJ, Valentijn A, David C, Rannard SP, O'Neill PM, Aljayyoussi G, Pennington SH, Ward SA, Hill A, Back DJ, Khoo SH, Bray PG, Biagini GA, Owen A. Prioritization of Anti-SARS-Cov-2 Drug Repurposing Opportunities Based on Plasma and Target Site Concentrations Derived from their Established Human Pharmacokinetics. Clin Pharmacol Ther. 2020 Oct;108(4):775-790. doi: 10.1002/cpt.1909. Epub 2020 Jun 14.
- Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trialLink provided by the sponsor.
- Effectiveness of Ivermectin as add-on Therapy in COVID-19 ManagementLink provided by the sponsor.
- Individual participant dataSharing planned: No. SHARED VIA EMAIL IF OTHER RESEARCHERS REQUIRE IT
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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.
GILBERTO CR ARTEAGA, specialist principal investigator
MEXICAN SOCIAL SECURITY INSTITUTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin / Ivermectin / Ribaroxaban / Paracetamol and Azithromycin / Ribaroxaban / Paracetamol in people with Covid19, run by Gilberto Cruz Arteaga 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 8 inclusion and 1 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 16 Aug 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Aug 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?
Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. (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 NCT04673214, 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 16 Aug 2021.