Phytomedicines Versus Hydroxychloroquine as an Add on Therapy to Azythromycin in Asymptomatic Covid-19 Patients

Covid19 Clinical Trial

— PHYTCOVID-19  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04501965
• Other study ID #: IRDPMAG
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: June 1, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2020
• Source: Institute for Research and Development of Medicinal and Food Plants of Guinea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 231
• Est. completion date: September 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eligible patients are adults with COVID-19 confirmed by a positive PCR (Polymerase Chain Reaction) test and without symptoms

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Covid19

Intervention

Combination Product:
• Hydroxychloroquine/Azithromycine
Dual treatment with Hydroxychloroquine and Azythromycin
• Quinquina-Stevia/Azythromycin
Dual treatment with Quinquina/Stevia (3/0,5) and Azythromycin
• 4Plants/Azythromycin
Dual treatment with 4 plant species drug and Azythromycin

Locations

Country	Name	City	State
Guinea	Support Centers of Donka, Kenien and Gbessia	Conakry

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Research and Development of Medicinal and Food Plants of Guinea

Country where clinical trial is conducted

Guinea, 

References & Publications (20)

• WHO, 2013. WHO Traditional medicine strategy 2014-2023. https://www.who.int/medicines/publications/traditional/trm_strategy14_23/en/.

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. — View Citation

Baldé AM, Traoré MS, Baldé MA, Barry MS, Diallo A, Camara M, Traoré S, Kouyaté M, Traoré S, Ouo-Ouo S, Myanthé AL, Keita N, Haba NL, Goumou K, Bah F, Camara A, Diallo MS, Sylla M, Baldé ES, Diané S, Pieters L, Oularé K. Ethnomedical and ethnobotanical inv — View Citation

Baldé ES, Megalizzi V, Traoré MS, Cos P, Maes L, Decaestecker C, Pieters L, Baldé 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. — View Citation

Camara A, Haddad M, Reybier K, Traoré MS, Baldé MA, Royo J, Baldé AO, Batigne P, Haidara M, Baldé ES, Coste A, Baldé AM, Aubouy A. Terminalia albida treatment improves survival in experimental cerebral malaria through reactive oxygen species scavenging an — View Citation

Colson 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. — View Citation

D'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). pii: E85. doi: 10.3390/microorganisms8010085. Review. — View Citation

Langeder 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. Revie — View Citation

Li 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 — View Citation

Liu 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- — View Citation

Liu 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. — View Citation

Luo 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. 202 — View Citation

Magassouba FB, Diallo A, Kouyaté M, Mara F, Mara O, Bangoura O, Camara A, Traoré S, Diallo AK, Zaoro M, Lamah K, Diallo S, Camara G, Traoré S, Kéita A, Camara MK, Barry R, Kéita S, Oularé K, Barry MS, Donzo M, Camara K, Toté K, Berghe DV, Totté J, Pieters — View Citation

Mahase 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. — View Citation

Ni 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. — View Citation

Ren 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. — View Citation

Schlagenhauf 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. — View Citation

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 — View Citation

Tong 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. — View Citation

Traore MS, Baldé MA, Diallo MS, Baldé ES, Diané S, Camara A, Diallo A, Balde A, Keïta A, Keita SM, Oularé K, Magassouba FB, Diakité I, Diallo A, Pieters L, Baldé AM. Ethnobotanical survey on medicinal plants used by Guinean traditional healers in the trea — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic clearance of throat swabs or lower respiratory tract secretions	Virologic clearance from admission to discharge at days 3, 6 and 14	day 3 to day 14
Secondary	COVID-19 symptoms development	number of patients who developed fever, cough, and any other clinical sign typical of the disease	day 1 to day 14
Secondary	Adverse effects	number of participants who developed treatment-related adverse effects	day 1 to day 14
Secondary	Worsened condition	number of patients whose condition worsened on D14	day 1 to day 14