Covid19Phase 2PHYTCOVID-19NCT04501965
Phytomedicines Versus Hydroxychloroquine as an Add on Therapy to Azythromycin in Asymptomatic Covid-19 Patients
A Phase 2 study testing Hydroxychloroquine/Azithromycine, Quinquina-Stevia/Azythromycin and 4Plants/Azythromycin 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
Our previous work on plants has indicated significant antimalarial and antiviral activities. Of these plants, two recipes are proposed for evaluation for COVID-19. It is Cinchona, an antimalarial and a combination of 4 plants with antiviral, antimalarial, antitussive and anti-inflammatory properties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Hydroxychloroquine/Azithromycine, Quinquina-Stevia/Azythromycin and 4Plants/Azythromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 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 adults with COVID-19 confirmed by a positive PCR (Polymerase Chain Reaction) test and without symptoms
Who cannot join
- any patient hypersensitive to hydroxychloroquine or under traditional herbal treatment in the two weeks preceding inclusion,
- any patient with other acute or chronic illnesses such as heart failure, arterial hypertension, renal failure, hepatocellular failure, tuberculosis or unable to take the oral treatment;
- any patient for whom one of the treatments under study is contraindicated according to the doctor's opinion.
- pregnant women,
- severe neurological manifestations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation de l'efficacité et de la tolérance de Quinquina et d'un phytomédicament " ACAR " en Comparaison Avec l'Hydroxychloroquine Chez Des Adultes Malades de Covid-19 Sans symptômes
Our previous work on plants has indicated significant antimalarial and antiviral activities. Of these plants, two recipes are proposed for evaluation for COVID-19. It is Cinchona, an antimalarial and a combination of 4 plants with antiviral, antimalarial, antitussive and anti-inflammatory properties.
The phase II clinical trial, with three arms and at a rate of 77 patients per arm, received the approval of the National Committee for Ethics and Health Research. This is a non-inferiority test aimed at comparing the therapeutic impact in "add on" to Azithromycin, phytomedicines versus Hydroxychloroquine in asymptomatic COVID-19 patients.
After 10 days of treatment, viral clearance and symptom 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
All consenting subjects who meet 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. They are distributed randomly into three parallel groups, each arm having a different treatment modality. A balanced randomization by permutation block of 5 will be applied using the "Randomizer for Clinical Trial" application developed by the company Medsharing). Laboratory examinations are carried out according to the procedures and method by laboratories accredited in Guinea for the diagnosis of COVID19. Data is encoded, entered and processed using statistical software.
The comparison between the three cohorts will be made using either the Anova test for continuous variables or the chi-square test for categorical variables. The rate of change over time of virologic clearance, fever and other symptoms values as well as the differences for these rates between treatment arms will be tested using mixed-effects modeling.
The biological samples will be stored at the biobank of the National Institute of Public Health of Guinea.
- Conditions
- Covid19
- Being tested
- Hydroxychloroquine/Azithromycine, Quinquina-Stevia/Azythromycin, 4Plants/Azythromycin
- 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.
Hydroxychloroquine/AzithromycineCombination product
Dual treatment with Hydroxychloroquine and Azythromycin
Quinquina-Stevia/AzythromycinCombination product
Also called CILE
Dual treatment with Quinquina/Stevia (3/0,5) and Azythromycin
4Plants/AzythromycinCombination product
Also called ACAR
Dual treatment with 4 plant species drug and Azythromycin
| 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: Hydroxychloroquine/Azithromycine |
| Quinquina/Azythromycin | Experimental | Patients receive 3.5g tea bags of Cinchona/Stevia powder orally at the rate of 3 tea bags per day for 10 days Receives: Combination Product: Quinquina-Stevia/Azythromycin |
| 4plants/Azythromycin | Experimental | Participants received 4Plants powder in a 3.5g tea bag orally three 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: 4Plants/Azythromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virologic clearance of throat swabs or lower respiratory tract secretions
Virologic clearance from admission to discharge at days 3, 6 and 14
Measured: day 3 to day 14
Secondary outcomes (3)
COVID-19 symptoms development
number of patients who developed fever, cough, and any other clinical sign typical of the disease
Measured: day 1 to day 14
Adverse effects
number of participants who developed treatment-related adverse effects
Measured: day 1 to day 14
Worsened condition
number of patients whose condition worsened on D14
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 (20)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 symptom-free 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 are noted throughout the trial period. Clinical, paraclinical and laboratory examinations are occasionally provided. Viral clearance, side effects, and the onset of COVID symptoms are evaluated and the data is statistically processed.
- Masking
- None (open label)
- Enrolment
- 231 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
- Saliou Sow, Principal investigator, Infectious Disease Department - Donka National Hospital Conakry GuineaMohamed Cissé, Study chair, Faculté des Sciences et Techniques de Santé, Université GAN ConakryMamadou A Baldé, Study director, Institute for Research and Development of Medicinal and Food Plants of Guinea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501965
- Sponsor's protocol ID
- IRDPMAG
- Acronym
- PHYTCOVID-19
- Status last verified
- Jul 2020
- First submitted
- 3 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
Ayisi 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 12719004Balde 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 26900129Balde ES, Megalizzi V, Traore MS, Cos P, Maes L, Decaestecker C, Pieters L, Balde AM. In vitro antiprotozoal, antimicrobial and antitumor activity of Pavetta crassipes K. Schum leaf extracts. J Ethnopharmacol. 2010 Aug 9;130(3):529-35. doi: 10.1016/j.jep.2010.05.042. Epub 2010 May 31.
PubMed 20561931Camara A, Haddad M, Reybier K, Traore MS, Balde MA, Royo J, Balde AO, Batigne P, Haidara M, Balde ES, Coste A, Balde AM, Aubouy A. Terminalia albida treatment improves survival in experimental cerebral malaria through reactive oxygen species scavenging and anti-inflammatory properties. Malar J. 2019 Dec 18;18(1):431. doi: 10.1186/s12936-019-3071-9.
PubMed 31852507Colson 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 32145363D'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 31936284Ren JL, Zhang AH, Wang XJ. Corrigendum to "Traditional Chinese medicine for COVID-19 treatment" [Pharmacol. Res. 155 (2020) 104743]. Pharmacol Res. 2020 May;155:104768. doi: 10.1016/j.phrs.2020.104768. Epub 2020 Mar 25. No abstract available.
PubMed 32222346Langeder J, Grienke U, Chen Y, Kirchmair J, Schmidtke M, Rollinger JM. Natural products against acute respiratory infections: Strategies and lessons learned. J Ethnopharmacol. 2020 Feb 10;248:112298. doi: 10.1016/j.jep.2019.112298. Epub 2019 Oct 11.
PubMed 31610260Ni L, Zhou L, Zhou M, Zhao J, Wang DW. Combination of western medicine and Chinese traditional patent medicine in treating a family case of COVID-19. Front Med. 2020 Apr;14(2):210-214. doi: 10.1007/s11684-020-0757-x. Epub 2020 Mar 13.
PubMed 32170559Liu 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 16499032Liu 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 15366588Luo H, Tang QL, Shang YX, Liang SB, Yang M, Robinson N, Liu JP. Can Chinese Medicine Be Used for Prevention of Corona Virus Disease 2019 (COVID-19)? A Review of Historical Classics, Research Evidence and Current Prevention Programs. Chin J Integr Med. 2020 Apr;26(4):243-250. doi: 10.1007/s11655-020-3192-6. Epub 2020 Feb 17.
PubMed 32065348Magassouba FB, Diallo A, Kouyate M, Mara F, Mara O, Bangoura O, Camara A, Traore S, Diallo AK, Zaoro M, Lamah K, Diallo S, Camara G, Traore S, Keita A, Camara MK, Barry R, Keita S, Oulare K, Barry MS, Donzo M, Camara K, Tote K, Berghe DV, Totte J, Pieters L, Vlietinck AJ, Balde AM. Ethnobotanical survey and antibacterial activity of some plants used in Guinean traditional medicine. J Ethnopharmacol. 2007 Oct 8;114(1):44-53. doi: 10.1016/j.jep.2007.07.009. Epub 2007 Jul 14.
PubMed 17825510Mahase 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 32165426Schlagenhauf P, Grobusch MP, Maier JD, Gautret P. Repurposing antimalarials and other drugs for COVID-19. Travel Med Infect Dis. 2020 Mar-Apr;34:101658. doi: 10.1016/j.tmaid.2020.101658. Epub 2020 Apr 2. No abstract available.
PubMed 32247925
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
- Evaluation de l'efficacité et de la tolérance de Quinquina et d'un phytomédicament " ACAR " en Comparaison Avec l'Hydroxychloroquine Chez Des Adultes Malades de Covid-19 Sans symptômes
- ClinicalTrials.gov ID
- NCT04501965
- Acronym / sponsor ID
- PHYTCOVID-19 / IRDPMAG
- Conditions
- Covid19
- Keywords
- Treatment; clinical research
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 231 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.
Our previous work on plants has indicated significant antimalarial and antiviral activities. Of these plants, two recipes are proposed for evaluation for COVID-19. It is Cinchona, an antimalarial and a combination of 4 plants with antiviral, antimalarial, antitussive and anti-inflammatory properties.
The phase II clinical trial, with three arms and at a rate of 77 patients per arm, received the approval of the National Committee for Ethics and Health Research. This is a non-inferiority test aimed at comparing the therapeutic impact in "add on" to Azithromycin, phytomedicines versus Hydroxychloroquine in asymptomatic COVID-19 patients.
After 10 days of treatment, viral clearance and symptom 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
All consenting subjects who meet 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. They are distributed randomly into three parallel groups, each arm having a different treatment modality. A balanced randomization by permutation block of 5 will be applied using the "Randomizer for Clinical Trial" application developed by the company Medsharing). Laboratory examinations are carried out according to the procedures and method by laboratories accredited in Guinea for the diagnosis of COVID19. Data is encoded, entered and processed using statistical software.
The comparison between the three cohorts will be made using either the Anova test for continuous variables or the chi-square test for categorical variables. The rate of change over time of virologic clearance, fever and other symptoms values as well as the differences for these rates between treatment arms will be tested using mixed-effects modeling.
The biological samples will be stored 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 symptom-free 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 are noted throughout the trial period. Clinical, paraclinical and laboratory examinations are occasionally provided. Viral clearance, side effects, and the onset of COVID symptoms are evaluated and the data is statistically processed.
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine/Azythromycin | Active comparator | Combination Product: Hydroxychloroquine/AzithromycinePatients 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 |
| Quinquina/Azythromycin | Experimental | Combination Product: Quinquina-Stevia/AzythromycinPatients receive 3.5g tea bags of Cinchona/Stevia powder orally at the rate of 3 tea bags per day for 10 days |
| 4plants/Azythromycin | Experimental | Combination Product: 4Plants/AzythromycinParticipants received 4Plants powder in a 3.5g tea bag orally three 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 |
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 adults with COVID-19 confirmed by a positive PCR (Polymerase Chain Reaction) test and without symptoms
Key exclusion criteria (5 listed)
- any patient hypersensitive to hydroxychloroquine or under traditional herbal treatment in the two weeks preceding inclusion,
- any patient with other acute or chronic illnesses such as heart failure, arterial hypertension, renal failure, hepatocellular failure, tuberculosis or unable to take the oral treatment;
- any patient for whom one of the treatments under study is contraindicated according to the doctor's opinion.
- pregnant women,
- severe neurological manifestations
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 |
|---|---|---|
| Hydroxychloroquine/AzithromycineDual treatment with Hydroxychloroquine and Azythromycin | Combination product | Hydroxychloroquine/Azythromycin |
| Quinquina-Stevia/AzythromycinAlso: CILEDual treatment with Quinquina/Stevia (3/0,5) and Azythromycin | Combination product | Quinquina/Azythromycin |
| 4Plants/AzythromycinAlso: ACARDual treatment with 4 plant species drug and Azythromycin | Combination product | 4plants/Azythromycin |
Primary outcome
Virologic clearance of throat swabs or lower respiratory tract secretions
Time frame: day 3 to day 14
Virologic clearance from admission to discharge at days 3, 6 and 14
3 secondary outcomes
COVID-19 symptoms development
Time frame: day 1 to day 14
Adverse effects
Time frame: day 1 to day 14
Worsened condition
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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 20561931Balde ES, Megalizzi V, Traore MS, Cos P, Maes L, Decaestecker C, Pieters L, Balde AM. In vitro antiprotozoal, antimicrobial and antitumor activity of Pavetta crassipes K. Schum leaf extracts. J Ethnopharmacol. 2010 Aug 9;130(3):529-35. doi: 10.1016/j.jep.2010.05.042. Epub 2010 May 31.
- Results publication: PubMed 31852507Camara A, Haddad M, Reybier K, Traore MS, Balde MA, Royo J, Balde AO, Batigne P, Haidara M, Balde ES, Coste A, Balde AM, Aubouy A. Terminalia albida treatment improves survival in experimental cerebral malaria through reactive oxygen species scavenging and anti-inflammatory properties. Malar J. 2019 Dec 18;18(1):431. doi: 10.1186/s12936-019-3071-9.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 32222346Ren JL, Zhang AH, Wang XJ. Corrigendum to "Traditional Chinese medicine for COVID-19 treatment" [Pharmacol. Res. 155 (2020) 104743]. Pharmacol Res. 2020 May;155:104768. doi: 10.1016/j.phrs.2020.104768. Epub 2020 Mar 25. No abstract available.
- Results publication: PubMed 31610260Langeder J, Grienke U, Chen Y, Kirchmair J, Schmidtke M, Rollinger JM. Natural products against acute respiratory infections: Strategies and lessons learned. J Ethnopharmacol. 2020 Feb 10;248:112298. doi: 10.1016/j.jep.2019.112298. Epub 2019 Oct 11.
- Results publication: PubMed 32170559Ni L, Zhou L, Zhou M, Zhao J, Wang DW. Combination of western medicine and Chinese traditional patent medicine in treating a family case of COVID-19. Front Med. 2020 Apr;14(2):210-214. doi: 10.1007/s11684-020-0757-x. Epub 2020 Mar 13.
- Results publication: PubMed 16499032Liu 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.
- Results publication: 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.
- Results publication: PubMed 32065348Luo H, Tang QL, Shang YX, Liang SB, Yang M, Robinson N, Liu JP. Can Chinese Medicine Be Used for Prevention of Corona Virus Disease 2019 (COVID-19)? A Review of Historical Classics, Research Evidence and Current Prevention Programs. Chin J Integr Med. 2020 Apr;26(4):243-250. doi: 10.1007/s11655-020-3192-6. Epub 2020 Feb 17.
- 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 ...
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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.
Saliou Sow principal investigator
Infectious Disease Department - Donka National Hospital Conakry Guinea
Mohamed Cissé study chair
Faculté des Sciences et Techniques de Santé, Université GAN Conakry
Mamadou A Baldé study director
Institute for Research and Development of Medicinal and Food Plants of Guinea
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 Hydroxychloroquine/Azithromycine, Quinquina-Stevia/Azythromycin and 4Plants/Azythromycin 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 5 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?
Virologic 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 NCT04501965, which also lists 20 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.