Covid19Phase 2CANCOVID-19NCT04502342
Add on to Azythromycine, Phytomedicine and/or Antimalarial Drug vs Hydroxychloroquine in Uncomplicated COVID-19 Patients
A Phase 2 study testing Hydroxycloroquine and Azythromycine, Cospherunate/Azythromycine and Cospherunate/Phytomedicine/Azythromycien in people with Covid19, run by Institute for Research and Development of Medicinal and Food Plants of Guinea at 1 site in Guinea.
Trial summary
The phase II clinical trial, with three arms and at rate of 10 patients per arm, received the approval of the National Committee for Ethics and Health Research. This is a non inferiority test aimed to compare the efficacy and safety in add on to Azithromycin, an antimalarial drug, a treatment combination of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Hydroxycloroquine and Azythromycine, Cospherunate/Azythromycine and Cospherunate/Phytomedicine/Azythromycien
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGuinea
- Study dates
- 1 Jun 2020to 30 Sep 2020
- 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
- eligible patients are symptomatic adults with COVID-19 confirmed by a positive Polymerase Chain Reaction test without complications
Who cannot join
- any patient herpersensitive to hydroxychloroquine or under antimalarial treatment in the 2 weeks preceding inclusion;
- any patient with a complication who must be taken care of in an Emergency or Intensive Care Unit;
- any patient with other acute or chronic ilnesses such as heart failure, arterial hypertension, renal failure, hepatocellular failure, tuberculosis or unable to take the oral the oral treatment;
- any patient for whom one of the treatments under study is contraindicated according to the doctor's opinion;
- pregant women;
- severe neurological manifestations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Évaluationefficacité et tolérance d'Une médication à Base de Cosphérunate et d'un phytomédicament Antiviral Par Voie Orale en Comparaison Avec un Traitement à Base d'Hydroxychloroquine Chez Des Adultes Malades Covid-19 Sans Complications
The phase II clinical trial, with three arms and at rate of 10 patients per arm, received the approval of the National Committee for Ethics and Health Research. This is a non inferiority test aimed to compare the efficacy and safety in add on to Azithromycin, an antimalarial drug, a treatment combination of the antimalrial drug with an antiviral phytomedicine versus Hydroxychloroquine in COVID-19 patients without complications.
During the treatment, viral clearance, adverse effects related to treatment, and symptoms progression will be assessed on days 3, 6 and 14. Clinical, paraclinical and laboratory tests will be performed throughout the 3-month trial. Ethical and deontological considerations will be applied.
Read the detailed description
The patient who has signed the informed consent for participation in the study will be immediately taken care of by the investigating clinicians. The clinician will determine the history of the disease and identify any clinical signs shown by the patient. Clinical data will be recorded in the patient's medical file. At the end of the clinical examination, the investigating clinician will draw up the report of the biological examinations.
Laboratory examinations will be carried out according to the procedures and method by accredited laboratories in Guinea (National Institute of Public Health; Hemorrhagic Fevers Laboratory; CREMS - Kindia Laboratory; Institut Pasteur de Guinée) for the diagnosis of COVID19.
After inclusion, patients are assigned by randomization into separate treatment arms with 10 patients per arm. They remain in these treatment arms for the duration of the trial, analysis, and follow-up activities. A random sequence will be generated and implemented so as to randomize.
The treatments will be made available to investigative clinicians by the Institute for Research and Development of Medicinal and Food Plants of Guinea.
All subjects meeting the inclusion criteria will benefit from an individual file which will include data relating to general information, the complete clinical examination and the paraclinical examination. The data will be coded, entered and processed using statistical software. Data entry quality control will be performed on all files. The selected patients are distributed randomly into 3 parallel arms, each arm having a different treatment modality.
A homogeneity test on the main socio-demographic variables (age, sex, weight, hemoglobin level, etc.) will be carried out between the different treatment arms before any specific analysis. Baseline characteristics and treatment of subjects in arms 1, 2 and 3 will be presented as medians, ranges for all parameters such as clinical, anthropometric, biochemical values and as percentages or numbers for symptoms. The comparison between the three cohorts will be made using either the Anova test for continuous variables or the chi2 test for categorical variables.
The rate of change over time of virologic clearance, fever and other symptom values as well as the differences for these rates between treatment arms will be tested using mixed-effects modeling.
The duration of the trial is 20 days for each patient recruited. In anticipation of future analyzes, the biological samples will be kept at the biobank of the National Institute of Public Health of Guinea.
- Conditions
- Covid19
- Being tested
- Hydroxycloroquine and Azythromycine, Cospherunate/Azythromycine, Cospherunate/Phytomedicine/Azythromycien
- Keywords
- Treatment; clinical research
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxycloroquine and AzythromycineCombination product
dual treatment with Hydroxycloroquine and Azythromycine
Cospherunate/AzythromycineCombination product
dual treatment with Cospherunate and Azythromycine
Cospherunate/Phytomedicine/AzythromycienCombination product
Also called Cospherunate/Asen/Azythromycine
triple treatment with Cospherunate, Asen and Azythromycine
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine/Azythromycin | Active comparator | Patients received Hydroxychloroquine 200 mg tablet orally 3 times daily for 10 days and Azythromycine 250 mg orally at the rate of 2 tablets the first day, then one tablet for 5 days. Receives: Combination Product: Hydroxycloroquine and Azythromycine |
| Cospherunate/Azithromycine | Experimental | Patients received Cospherunate (50 mg Artésunate/125 mg Amodiaquine) at the rate of 2 tablets orally twice daily for 6 days and Azythromycine 250 mg orally at the rate of 2 tablets the first day, then one tablet for 5 days. Receives: Combination Product: Cospherunate/Azythromycine |
| Cospherunate/Phytomedicine/Azithromycine | Experimental | Patients received Cospherunate (50 mg Artésunate/125 mg Amodiaquine) at the rate of 2 tablets orally twice daily for 6 days and Phytomedicine tablet 350 mg at the rate of 2 tablets orally twice daily for 6 days, and Azythromycine 250 mg orally at the rate of 2 tablets the first day, then one tablet for 5 days. Receives: Combination Product: Cospherunate/Phytomedicine/Azythromycien |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virological clearance of throat swabs or lower respiratory tract secretions
Virological clearance from admission to discharge at days 3, 6 and 14
Measured: day 3 to day 14
Secondary outcomes (3)
Adverse effects
number of patients who developed treatment-related adverse effects
Measured: day 1 to day 14
Worsened conditions
number of patients whose conditions worsened
Measured: day 1 to day 14
COVID-19 symptoms
number of patients whose fever, cough and any other clinical sign observed on introduction have resolved
Measured: day 1 to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Jun 2020
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible consenting symptomatic patients with COVID-19 confirmed by a positive Polymerase Chain Reaction test were subjected to the 10 days of treatment allocated to each of the 3 arms of the trial. Virological clearance is assessed on days 3, 6 and 14. Side effects and the onset of COVID symptoms are evaluated throughout the trial period. Clinical, paraclinical and laboratory examinations are occasionally provided. The data are statiscally processed.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Research and Development of Medicinal and Food Plants of Guinea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mamadou A Baldé, Study director, RDIMFPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502342
- Sponsor's protocol ID
- RDIMFPG
- Acronym
- CANCOVID-19
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The samples stored in the biobank could be shared with other researchers with a view to in-depth analyzes in order to dig for example a posteriori on the hypotheses relating to the blood levels of the phytomedicine, hydroxychloroquine, etc., cardio-metabolic biological markers infarction, insulin sensitivity, thrombosis, specific antibodies, genetic markers, viral markers ...
Publications
Sohrabi C, Alsafi Z, O'Neill N, Khan M, Kerwan A, Al-Jabir A, Iosifidis C, Agha R. World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19). Int J Surg. 2020 Apr;76:71-76. doi: 10.1016/j.ijsu.2020.02.034. Epub 2020 Feb 26.
PubMed 32112977Mahase E. Covid-19: WHO declares pandemic because of "alarming levels" of spread, severity, and inaction. BMJ. 2020 Mar 12;368:m1036. doi: 10.1136/bmj.m1036. No abstract available.
PubMed 32165426Colson P, Rolain JM, Lagier JC, Brouqui P, Raoult D. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents. 2020 Apr;55(4):105932. doi: 10.1016/j.ijantimicag.2020.105932. Epub 2020 Mar 4. No abstract available.
PubMed 32145363Balde AM, Traore MS, Balde MA, Barry MS, Diallo A, Camara M, Traore S, Kouyate M, Traore S, Ouo-Ouo S, Myanthe AL, Keita N, Haba NL, Goumou K, Bah F, Camara A, Diallo MS, Sylla M, Balde ES, Diane S, Pieters L, Oulare K. Ethnomedical and ethnobotanical investigations on the response capacities of Guinean traditional health practioners in the management of outbreaks of infectious diseases: The case of the Ebola virus epidemic. J Ethnopharmacol. 2016 Apr 22;182:137-49. doi: 10.1016/j.jep.2016.02.021. Epub 2016 Feb 18.
PubMed 26900129Ayisi NK, Nyadedzor C. Comparative in vitro effects of AZT and extracts of Ocimum gratissimum, Ficus polita, Clausena anisata, Alchornea cordifolia, and Elaeophorbia drupifera against HIV-1 and HIV-2 infections. Antiviral Res. 2003 Mar;58(1):25-33. doi: 10.1016/s0166-3542(02)00166-3.
PubMed 12719004D'Alessandro S, Scaccabarozzi D, Signorini L, Perego F, Ilboudo DP, Ferrante P, Delbue S. The Use of Antimalarial Drugs against Viral Infection. Microorganisms. 2020 Jan 8;8(1):85. doi: 10.3390/microorganisms8010085.
PubMed 31936284Haladyj E, Sikora M, Felis-Giemza A, Olesinska M. Antimalarials - are they effective and safe in rheumatic diseases? Reumatologia. 2018;56(3):164-173. doi: 10.5114/reum.2018.76904. Epub 2018 Jun 30.
PubMed 30042604Das AK. Anticancer Effect of AntiMalarial Artemisinin Compounds. Ann Med Health Sci Res. 2015 Mar-Apr;5(2):93-102. doi: 10.4103/2141-9248.153609.
PubMed 25861527Gwitira I, Murwira A, Mberikunashe J, Masocha M. Spatial overlaps in the distribution of HIV/AIDS and malaria in Zimbabwe. BMC Infect Dis. 2018 Nov 27;18(1):598. doi: 10.1186/s12879-018-3513-y.
PubMed 30482166Santana Vdos S, Lavezzo LC, Mondini A, Terzian AC, Bronzoni RV, Rossit AR, Machado RL, Rahal P, Nogueira MC, Nogueira ML. Concurrent Dengue and malaria in the Amazon region. Rev Soc Bras Med Trop. 2010 Sep-Oct;43(5):508-11. doi: 10.1590/s0037-86822010000500007.
PubMed 21085859Liu DH, Liang BZ, Huang LY. [Clinical observation on the preventive effect of kangdu bufei decoction on acute severe respiratory syndrome]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2004 Aug;24(8):685-8. Chinese.
PubMed 15366588Tong X, Li A, Zhang Z, Duan J, Chen X, Hua C, Zhao D, Xu Y, Shi X, Li P, Tian X, Lin F, Cao Y, Jin L, Chang M, Wang Y. TCM treatment of infectious atypical pneumonia--a report of 16 cases. J Tradit Chin Med. 2004 Dec;24(4):266-9.
PubMed 15688692Liu BY, He LY, Liang ZW, Tong XY, Hu JQ, Jiao Q, Ni Q, Liu XM, Xie YM, Li P, Gao FZ, Wen TC, Liu WM. [Effect of glucocorticoid with traditional Chinese medicine in severe acute aespiratory syndrome (SARS)]. Zhongguo Zhong Yao Za Zhi. 2005 Dec;30(23):1874-7. Chinese.
PubMed 16499032Li Y, Liu X, Guo L, Li J, Zhong D, Zhang Y, Clarke M, Jin R. Traditional Chinese herbal medicine for treating novel coronavirus (COVID-19) pneumonia: protocol for a systematic review and meta-analysis. Syst Rev. 2020 Apr 8;9(1):75. doi: 10.1186/s13643-020-01343-4.
PubMed 32268923Efferth T, Romero MR, Wolf DG, Stamminger T, Marin JJ, Marschall M. The antiviral activities of artemisinin and artesunate. Clin Infect Dis. 2008 Sep 15;47(6):804-11. doi: 10.1086/591195.
PubMed 18699744
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Évaluationefficacité et tolérance d'Une médication à Base de Cosphérunate et d'un phytomédicament Antiviral Par Voie Orale en Comparaison Avec un Traitement à Base d'Hydroxychloroquine Chez Des Adultes Malades Covid-19 Sans Complications
- ClinicalTrials.gov ID
- NCT04502342
- Acronym / sponsor ID
- CANCOVID-19 / RDIMFPG
- Conditions
- Covid19
- Keywords
- Treatment; clinical research
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institute for Research and Development of Medicinal and Food Plants of GuineaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 6 Aug 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.
The phase II clinical trial, with three arms and at rate of 10 patients per arm, received the approval of the National Committee for Ethics and Health Research. This is a non inferiority test aimed to compare the efficacy and safety in add on to Azithromycin, an antimalarial drug, a treatment combination of the antimalrial drug with an antiviral phytomedicine versus Hydroxychloroquine in COVID-19 patients without complications.
During the treatment, viral clearance, adverse effects related to treatment, and symptoms progression will be assessed on days 3, 6 and 14. Clinical, paraclinical and laboratory tests will be performed throughout the 3-month trial. Ethical and deontological considerations will be applied.
Detailed description
The patient who has signed the informed consent for participation in the study will be immediately taken care of by the investigating clinicians. The clinician will determine the history of the disease and identify any clinical signs shown by the patient. Clinical data will be recorded in the patient's medical file. At the end of the clinical examination, the investigating clinician will draw up the report of the biological examinations.
Laboratory examinations will be carried out according to the procedures and method by accredited laboratories in Guinea (National Institute of Public Health; Hemorrhagic Fevers Laboratory; CREMS - Kindia Laboratory; Institut Pasteur de Guinée) for the diagnosis of COVID19.
After inclusion, patients are assigned by randomization into separate treatment arms with 10 patients per arm. They remain in these treatment arms for the duration of the trial, analysis, and follow-up activities. A random sequence will be generated and implemented so as to randomize.
The treatments will be made available to investigative clinicians by the Institute for Research and Development of Medicinal and Food Plants of Guinea.
All subjects meeting the inclusion criteria will benefit from an individual file which will include data relating to general information, the complete clinical examination and the paraclinical examination. The data will be coded, entered and processed using statistical software. Data entry quality control will be performed on all files. The selected patients are distributed randomly into 3 parallel arms, each arm having a different treatment modality.
A homogeneity test on the main socio-demographic variables (age, sex, weight, hemoglobin level, etc.) will be carried out between the different treatment arms before any specific analysis. Baseline characteristics and treatment of subjects in arms 1, 2 and 3 will be presented as medians, ranges for all parameters such as clinical, anthropometric, biochemical values and as percentages or numbers for symptoms. The comparison between the three cohorts will be made using either the Anova test for continuous variables or the chi2 test for categorical variables.
The rate of change over time of virologic clearance, fever and other symptom values as well as the differences for these rates between treatment arms will be tested using mixed-effects modeling.
The duration of the trial is 20 days for each patient recruited. In anticipation of future analyzes, the biological samples will be kept at the biobank of the National Institute of Public Health of Guinea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Eligible consenting symptomatic patients with COVID-19 confirmed by a positive Polymerase Chain Reaction test were subjected to the 10 days of treatment allocated to each of the 3 arms of the trial. Virological clearance is assessed on days 3, 6 and 14. Side effects and the onset of COVID symptoms are evaluated throughout the trial period. Clinical, paraclinical and laboratory examinations are occasionally provided. The data are statiscally processed.
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine/Azythromycin | Active comparator | Combination Product: Hydroxycloroquine and AzythromycinePatients received Hydroxychloroquine 200 mg tablet orally 3 times daily for 10 days and Azythromycine 250 mg orally at the rate of 2 tablets the first day, then one tablet for 5 days. |
| Cospherunate/Azithromycine | Experimental | Combination Product: Cospherunate/AzythromycinePatients received Cospherunate (50 mg Artésunate/125 mg Amodiaquine) at the rate of 2 tablets orally twice daily for 6 days and Azythromycine 250 mg orally at the rate of 2 tablets the first day, then one tablet for 5 days. |
| Cospherunate/Phytomedicine/Azithromycine | Experimental | Combination Product: Cospherunate/Phytomedicine/AzythromycienPatients received Cospherunate (50 mg Artésunate/125 mg Amodiaquine) at the rate of 2 tablets orally twice daily for 6 days and Phytomedicine tablet 350 mg at the rate of 2 tablets orally twice daily for 6 days, and Azythromycine 250 mg orally at the rate of 2 tablets the first day, then one tablet for 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- eligible patients are symptomatic adults with COVID-19 confirmed by a positive Polymerase Chain Reaction test without complications
Key exclusion criteria (6 listed)
- any patient herpersensitive to hydroxychloroquine or under antimalarial treatment in the 2 weeks preceding inclusion;
- any patient with a complication who must be taken care of in an Emergency or Intensive Care Unit;
- any patient with other acute or chronic ilnesses such as heart failure, arterial hypertension, renal failure, hepatocellular failure, tuberculosis or unable to take the oral the oral treatment;
- any patient for whom one of the treatments under study is contraindicated according to the doctor's opinion;
- pregant women;
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 |
|---|---|---|
| Hydroxycloroquine and Azythromycinedual treatment with Hydroxycloroquine and Azythromycine | Combination product | Hydroxychloroquine/Azythromycin |
| Cospherunate/Azythromycinedual treatment with Cospherunate and Azythromycine | Combination product | Cospherunate/Azithromycine |
| Cospherunate/Phytomedicine/AzythromycienAlso: Cospherunate/Asen/Azythromycinetriple treatment with Cospherunate, Asen and Azythromycine | Combination product | Cospherunate/Phytomedicine/Azithromycine |
Primary outcome
Virological clearance of throat swabs or lower respiratory tract secretions
Time frame: day 3 to day 14
Virological clearance from admission to discharge at days 3, 6 and 14
3 secondary outcomes
Adverse effects
Time frame: day 1 to day 14
Worsened conditions
Time frame: day 1 to day 14
COVID-19 symptoms
Time frame: day 1 to day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Background: PubMed 32112977Sohrabi C, Alsafi Z, O'Neill N, Khan M, Kerwan A, Al-Jabir A, Iosifidis C, Agha R. World Health Organization declares global emergency: A review of the 2019 novel coronavirus (COVID-19). Int J Surg. 2020 Apr;76:71-76. doi: 10.1016/j.ijsu.2020.02.034. Epub 2020 Feb 26.
- Background: PubMed 32165426Mahase E. Covid-19: WHO declares pandemic because of "alarming levels" of spread, severity, and inaction. BMJ. 2020 Mar 12;368:m1036. doi: 10.1136/bmj.m1036. No abstract available.
- Background: PubMed 32145363Colson P, Rolain JM, Lagier JC, Brouqui P, Raoult D. Chloroquine and hydroxychloroquine as available weapons to fight COVID-19. Int J Antimicrob Agents. 2020 Apr;55(4):105932. doi: 10.1016/j.ijantimicag.2020.105932. Epub 2020 Mar 4. No abstract available.
- Background: PubMed 26900129Balde AM, Traore MS, Balde MA, Barry MS, Diallo A, Camara M, Traore S, Kouyate M, Traore S, Ouo-Ouo S, Myanthe AL, Keita N, Haba NL, Goumou K, Bah F, Camara A, Diallo MS, Sylla M, Balde ES, Diane S, Pieters L, Oulare K. Ethnomedical and ethnobotanical investigations on the response capacities of Guinean traditional health practioners in the management of outbreaks of infectious diseases: The case of the Ebola virus epidemic. J Ethnopharmacol. 2016 Apr 22;182:137-49. doi: 10.1016/j.jep.2016.02.021. Epub 2016 Feb 18.
- Background: PubMed 12719004Ayisi NK, Nyadedzor C. Comparative in vitro effects of AZT and extracts of Ocimum gratissimum, Ficus polita, Clausena anisata, Alchornea cordifolia, and Elaeophorbia drupifera against HIV-1 and HIV-2 infections. Antiviral Res. 2003 Mar;58(1):25-33. doi: 10.1016/s0166-3542(02)00166-3.
- Background: PubMed 31936284D'Alessandro S, Scaccabarozzi D, Signorini L, Perego F, Ilboudo DP, Ferrante P, Delbue S. The Use of Antimalarial Drugs against Viral Infection. Microorganisms. 2020 Jan 8;8(1):85. doi: 10.3390/microorganisms8010085.
- Background: PubMed 30042604Haladyj E, Sikora M, Felis-Giemza A, Olesinska M. Antimalarials - are they effective and safe in rheumatic diseases? Reumatologia. 2018;56(3):164-173. doi: 10.5114/reum.2018.76904. Epub 2018 Jun 30.
- Background: PubMed 25861527Das AK. Anticancer Effect of AntiMalarial Artemisinin Compounds. Ann Med Health Sci Res. 2015 Mar-Apr;5(2):93-102. doi: 10.4103/2141-9248.153609.
- Background: PubMed 30482166Gwitira I, Murwira A, Mberikunashe J, Masocha M. Spatial overlaps in the distribution of HIV/AIDS and malaria in Zimbabwe. BMC Infect Dis. 2018 Nov 27;18(1):598. doi: 10.1186/s12879-018-3513-y.
- Background: PubMed 21085859Santana Vdos S, Lavezzo LC, Mondini A, Terzian AC, Bronzoni RV, Rossit AR, Machado RL, Rahal P, Nogueira MC, Nogueira ML. Concurrent Dengue and malaria in the Amazon region. Rev Soc Bras Med Trop. 2010 Sep-Oct;43(5):508-11. doi: 10.1590/s0037-86822010000500007.
- Background: PubMed 15366588Liu DH, Liang BZ, Huang LY. [Clinical observation on the preventive effect of kangdu bufei decoction on acute severe respiratory syndrome]. Zhongguo Zhong Xi Yi Jie He Za Zhi. 2004 Aug;24(8):685-8. Chinese.
- Background: PubMed 15688692Tong X, Li A, Zhang Z, Duan J, Chen X, Hua C, Zhao D, Xu Y, Shi X, Li P, Tian X, Lin F, Cao Y, Jin L, Chang M, Wang Y. TCM treatment of infectious atypical pneumonia--a report of 16 cases. J Tradit Chin Med. 2004 Dec;24(4):266-9.
- Individual participant dataSharing planned: Yes. The samples stored in the biobank could be shared with other researchers with a view to in-depth analyzes in order to dig for example a posteriori on the hypotheses relating to the blood levels of the phytomedicine, hydroxychloroquine, etc., cardio-metabolic biological markers infarction, insulin sensitivity, thrombosis, specific antibodies, genetic markers, viral markers ...
Related trials for Covid19
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.
Mamadou A Baldé study director
RDIMFPG
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 Hydroxycloroquine and Azythromycine, Cospherunate/Azythromycine and Cospherunate/Phytomedicine/Azythromycien in people with Covid19, run by Institute for Research and Development of Medicinal and Food Plants of Guinea at 1 site in Guinea.
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 1 inclusion and 6 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 7 Aug 2020. 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 Guinea. 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 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?
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?
Virological clearance of throat swabs or lower respiratory tract secretions (time frame: day 3 to day 14). 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 NCT04502342, which also lists 16 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 7 Aug 2020.