ComplicationPhase 3NCT04788355
Prevention of Complications (SARS-CoV-2): Clinical Study
A Phase 3 study testing Group Hydroxychloroquine, Group Hydroxychloroquine and apixaban and Group Apixaban in people with Complication, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial summary
Viral diseases have always posed a threat to public health. Recently, the SARS-Cov2 virus spread in an epidemic that began in China and soon spread globally, making its study extremely relevant, in order to seek mechanisms to combat it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication
- What is being tested?
- Group Hydroxychloroquine, Group Hydroxychloroquine and apixaban and Group Apixaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2020to 23 Dec 2020
- Phase
- Phase 3
- 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
- Patients with suspected or confirmed covid-19, above 18 years old
- Patients with time between symptom onset and inclusion ≤ 14 days
- Patients with time between hospital stay and inclusion ≤ 48 hours
Who cannot join
- Patients tested negative for covid-19 by rt-pcr, serological or rapid test method
- Patients unable to swallow for any reason
- Patients with an extended qt interval, defined as a corrected qt (qtc) for heart rate above 450 ms for men and 470 ms for women
- Patients with liver toxicity, defined as ast / alt or increased bilirubin
- Patients with ventricular arrhythmias
- Patients with bleeding, major hematoma or blood dyscrasia;
- Patients who, at any time during the process, choose to give up participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hydroxychloroquine and Apixaban: Analysis of Physiological Parameters for the Prevention of Complications in Patients With Infection With the New Coronavirus (Covid-19). A Randomized Clinical Trial
Viral diseases have always posed a threat to public health. Recently, the SARS-Cov2 virus spread in an epidemic that began in China and soon spread globally, making its study extremely relevant, in order to seek mechanisms to combat it. Therefore, this study seeks to evaluate the benefit of using Hydroxychloroquine with or without Apixaban in the early treatment of patients with suspected COVID-19. Prospective, randomized, double-blind, controlled study, performed at Hospital das Clínicas Samuel Libânio (Universidade do Vale do Sapucaí) UNIVÁS, Pouso Alegre, Minas Gerais, Brasil. Patients treated in the emergency department who are reported as suspected cases of COVID-19 patients will be included, according to current guidelines. Will be randomized into 4 groups: Hydroxychloroquine, Hydroxychloroquine + Apixabana, only Apixabana and Control group, all receiving standard treatment recommended. Included patients will be monitored during hospitalization or remotely assisted in home treatment. Clinical, laboratory, electrocardiographic and image evaluation criteria will be considered to assess the evolution in 7 and 14 days after inclusion. Results will be subjected to appropriate statistical analysis, with sample calculation. An early therapeutic approach is proposed in suspected and confirmed patients with COVID-19, with the hope of reducing hospitalizations and severe forms of the disease.
Read the detailed description
The early administration of HCQ or in association with apixaban, could prevent worsening of suspected COVID-19, as well as preventing hospitalizations and the need for intensive treatment. In patients with mild to moderate disease, the use of hydroxychloroquine or hydroxychloroquine with apixaban or apixaban alone, could be able to reduce disease progression on an ordinal scale of outcome (including use of mechanical ventilation and death) and decrease the likelihood of hospitalization or worsening of clinical conditions.
- Conditions
- Complication
- Being tested
- Control group (standard hospital treatment), Group Hydroxychloroquine, Group Hydroxychloroquine and apixaban, Group Apixaban
- Keywords
- Complications, Novel coronavirus 2019, SARS-CoV-2, Chloroquine, Anticoagulants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control group (standard hospital treatment)Drug
Also called Drug protocols recommended by WHO and the Ministry of Health that make up the standard hospital treatment
Medications defined by the hospital involved in the study
Group HydroxychloroquineDrug
Also called Hydroxychloroquine associated with standard treatment of the hospital involved in the study
Patients in this group will receive hydroxychloroquine orally 200 mg every 12 hours for 7 days. In addition, patients in this group will receive standard medication for COVID-19 which is part of the hospital protocol involved in the study.
Group Hydroxychloroquine and apixabanDrug
Also called Hydroxychloroquine, Apixaban and standard treatment
Patients in this group will receive hydroxychloroquine orally 200 mg every 12 hours for 7 days + apixaban orally 2.5 mg every 12 hours, also for 14 days (prophylactic dose). In addition, patients in this group will receive standard medication, which is the protocol of the hospital involved in the study.
Group ApixabanDrug
Also called Apixaban and standard treatment
Patients in this group will receive apixaban 2.5 mg orally every 12 hours, also for 14 days (prophylactic dose). In addition, patients in this group will receive standard medication, which is the protocol of the hospital involved in the study.
| Study group | Role | What they receive |
|---|---|---|
| Control Group standard treatment | Active comparator | Patients will be treated only with standard hospital treatment Receives: Drug: Control group (standard hospital treatment) |
| Group Hydroxychloroquine | Experimental | Patients will be treated with Hydroxychloroquine associated with standard hospital treatment Receives: Drug: Control group (standard hospital treatment); Drug: Group Hydroxychloroquine |
| Group Hydroxychloroquine e Apixaban | Experimental | Patients will be treated with Hydroxychloroquine associated with apixaban and standard hospital treatment Receives: Drug: Control group (standard hospital treatment); Drug: Group Hydroxychloroquine and apixaban |
| Group Apixabana | Experimental | Patients will be treated with apixaban associated with standard hospital treatment Receives: Drug: Control group (standard hospital treatment); Drug: Group Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients in home isolation will be followed for (telemedicine) 14 days. The Beck scale will assess anxiety. Questions will be asked to patients about their health conditions. The answers will be tabulated in a spreadsheet composed of the following result
The Beck scale will assess anxiety. Questions asked by telemedicine: cough, dyspnea, fatigue, malaise, myalgia, runny nose, odynophagia, anosmia, ageusia, headache, anorexia, abdominal pain, conjunctival congestion, diarrhea, nausea, vomiting, palpitation, bleeding, atypical symptoms. The parameters for such telemedicine evaluations were: yes or no.
Measured: 14 evaluation days after inclusion in the study
Secondary outcomes (1)
Assessment of the presence or absence of secondary complications for patients in home isolation or hospitalized, after using the drugs.
The relationship between the use of medications in the initial interventions and the presence or absence of secondary complications will be assessed both for patients in home isolation and for hospitalized patients. As for patients who are hospitalized, the following topics will be included in the table: use of oxygen therapy, mechanical ventilation, death. The parameters for answers will be yes or no.
Measured: 14 evaluation days after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Jul 2020
- Primary completion15 Nov 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Clinical study that will evaluate the action of drugs combined or not to reduce complications of patients with covid 19
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Apsen Farmaceutica S.A., Dermadia, Methodos Laboratory, Biofarma
- Responsible party
- Principal investigator, José Dias da Silva Neto, Universidade do Vale do Sapucai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788355
- Sponsor's protocol ID
- HA and A COVID 19
- Status last verified
- Mar 2021
- First submitted
- 5 Sep 2020
- Last updated
- 9 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine and Apixaban: Analysis of Physiological Parameters for the Prevention of Complications in Patients With Infection With the New Coronavirus (Covid-19). A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04788355
- Acronym / sponsor ID
- HA and A COVID 19
- Conditions
- Complication
- Keywords
- Complications, Novel coronavirus 2019, SARS-CoV-2, Chloroquine, Anticoagulants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Collaborators
- Pfizer, Apsen Farmaceutica S.A., Dermadia, Methodos Laboratory, Biofarma
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 9 Mar 2021 (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.
Viral diseases have always posed a threat to public health. Recently, the SARS-Cov2 virus spread in an epidemic that began in China and soon spread globally, making its study extremely relevant, in order to seek mechanisms to combat it. Therefore, this study seeks to evaluate the benefit of using Hydroxychloroquine with or without Apixaban in the early treatment of patients with suspected COVID-19. Prospective, randomized, double-blind, controlled study, performed at Hospital das Clínicas Samuel Libânio (Universidade do Vale do Sapucaí) UNIVÁS, Pouso Alegre, Minas Gerais, Brasil. Patients treated in the emergency department who are reported as suspected cases of COVID-19 patients will be included, according to current guidelines. Will be randomized into 4 groups: Hydroxychloroquine, Hydroxychloroquine + Apixabana, only Apixabana and Control group, all receiving standard treatment recommended. Included patients will be monitored during hospitalization or remotely assisted in home treatment. Clinical, laboratory, electrocardiographic and image evaluation criteria will be considered to assess the evolution in 7 and 14 days after inclusion. Results will be subjected to appropriate statistical analysis, with sample calculation. An early therapeutic approach is proposed in suspected and confirmed patients with COVID-19, with the hope of reducing hospitalizations and severe forms of the disease.
Detailed description
The early administration of HCQ or in association with apixaban, could prevent worsening of suspected COVID-19, as well as preventing hospitalizations and the need for intensive treatment. In patients with mild to moderate disease, the use of hydroxychloroquine or hydroxychloroquine with apixaban or apixaban alone, could be able to reduce disease progression on an ordinal scale of outcome (including use of mechanical ventilation and death) and decrease the likelihood of hospitalization or worsening of clinical conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- Clinical study that will evaluate the action of drugs combined or not to reduce complications of patients with covid 19
| Arm | Type | Receives |
|---|---|---|
| Control Group standard treatment | Active comparator | Drug: Control group (standard hospital treatment)Patients will be treated only with standard hospital treatment |
| Group Hydroxychloroquine | Experimental | Drug: Control group (standard hospital treatment), Drug: Group HydroxychloroquinePatients will be treated with Hydroxychloroquine associated with standard hospital treatment |
| Group Hydroxychloroquine e Apixaban | Experimental | Drug: Control group (standard hospital treatment), Drug: Group Hydroxychloroquine and apixabanPatients will be treated with Hydroxychloroquine associated with apixaban and standard hospital treatment |
| Group Apixabana | Experimental | Drug: Control group (standard hospital treatment), Drug: Group ApixabanPatients will be treated with apixaban associated with standard hospital treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with suspected or confirmed covid-19, above 18 years old
- Patients with time between symptom onset and inclusion ≤ 14 days
- Patients with time between hospital stay and inclusion ≤ 48 hours
Key exclusion criteria (7 listed)
- Patients tested negative for covid-19 by rt-pcr, serological or rapid test method
- Patients unable to swallow for any reason
- Patients with an extended qt interval, defined as a corrected qt (qtc) for heart rate above 450 ms for men and 470 ms for women
- Patients with liver toxicity, defined as ast / alt or increased bilirubin
- Patients with ventricular arrhythmias
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 |
|---|---|---|
| Control group (standard hospital treatment)Also: Drug protocols recommended by WHO and the Ministry of Health that make up the standard hospital treatmentMedications defined by the hospital involved in the study | Drug | Control Group standard treatment, Group Apixabana, Group Hydroxychloroquine, Group Hydroxychloroquine e Apixaban |
| Group HydroxychloroquineAlso: Hydroxychloroquine associated with standard treatment of the hospital involved in the studyPatients in this group will receive hydroxychloroquine orally 200 mg every 12 hours for 7 days. In addition, patients in this group will receive standard medication for COVID-19 which is part of the hospital protocol involved in the study. | Drug | Group Hydroxychloroquine |
| Group Hydroxychloroquine and apixabanAlso: Hydroxychloroquine, Apixaban and standard treatmentPatients in this group will receive hydroxychloroquine orally 200 mg every 12 hours for 7 days + apixaban orally 2.5 mg every 12 hours, also for 14 days (prophylactic dose). In addition, patients in this group will receive standard medication, which is the protocol of the hospital involved in the study. | Drug | Group Hydroxychloroquine e Apixaban |
| Group ApixabanAlso: Apixaban and standard treatmentPatients in this group will receive apixaban 2.5 mg orally every 12 hours, also for 14 days (prophylactic dose). In addition, patients in this group will receive standard medication, which is the protocol of the hospital involved in the study. | Drug | Group Apixabana |
Primary outcome
Patients in home isolation will be followed for (telemedicine) 14 days. The Beck scale will assess anxiety. Questions will be asked to patients about their health conditions. The answers will be tabulated in a spreadsheet composed of the following result
Time frame: 14 evaluation days after inclusion in the study
The Beck scale will assess anxiety. Questions asked by telemedicine: cough, dyspnea, fatigue, malaise, myalgia, runny nose, odynophagia, anosmia, ageusia, headache, anorexia, abdominal pain, conjunctival congestion, diarrhea, nausea, vomiting, palpitation, bleeding, atypical symptoms. The parameters for such telemedicine evaluations were: yes or no.
1 secondary outcome
Assessment of the presence or absence of secondary complications for patients in home isolation or hospitalized, after using the drugs.
Time frame: 14 evaluation days after inclusion in the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Group Hydroxychloroquine, Group Hydroxychloroquine and apixaban and Group Apixaban in people with Complication, run by Universidade do Vale do Sapucai at 1 site in Brazil.
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 7 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 9 Mar 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patients in home isolation will be followed for (telemedicine) 14 days. The Beck scale will assess anxiety. Questions will be asked to patients about their health conditions. The answers will be tabulated in a spreadsheet composed of the following result (time frame: 14 evaluation days after inclusion in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2021.