<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04501965</url>
  </required_header>
  <id_info>
    <org_study_id>IRDPMAG</org_study_id>
    <nct_id>NCT04501965</nct_id>
  </id_info>
  <brief_title>Phytomedicines Versus Hydroxychloroquine as an Add on Therapy to Azythromycin in Asymptomatic Covid-19 Patients</brief_title>
  <acronym>PHYTCOVID-19</acronym>
  <official_title>Evaluation de l'efficacité et de la tolérance de Quinquina et d'un phytomédicament &quot; ACAR &quot; en Comparaison Avec l'Hydroxychloroquine Chez Des Adultes Malades de Covid-19 Sans symptômes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute for Research and Development of Medicinal and Food Plants of Guinea</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute for Research and Development of Medicinal and Food Plants of Guinea</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our previous work on plants has indicated significant antimalarial and antiviral activities.&#xD;
      Of these plants, two recipes are proposed for evaluation for COVID-19. It is Cinchona, an&#xD;
      antimalarial and a combination of 4 plants with antiviral, antimalarial, antitussive and&#xD;
      anti-inflammatory properties.&#xD;
&#xD;
      The phase II clinical trial, with three arms and at a rate of 77 patients per arm, received&#xD;
      the approval of the National Committee for Ethics and Health Research. This is a&#xD;
      non-inferiority test aimed at comparing the therapeutic impact in &quot;add on&quot; to Azithromycin,&#xD;
      phytomedicines versus Hydroxychloroquine in asymptomatic COVID-19 patients.&#xD;
&#xD;
      After 10 days of treatment, viral clearance and symptom progression will be assessed on days&#xD;
      3, 6 and 14. Clinical, paraclinical and laboratory tests will be performed throughout the&#xD;
      3-month trial. Ethical and deontological considerations will be applied&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All consenting subjects who meet the inclusion criteria will benefit from an individual file&#xD;
      which will include data relating to general information, the complete clinical examination&#xD;
      and the paraclinical examination. They are distributed randomly into three parallel groups,&#xD;
      each arm having a different treatment modality. A balanced randomization by permutation block&#xD;
      of 5 will be applied using the &quot;Randomizer for Clinical Trial&quot; application developed by the&#xD;
      company Medsharing). Laboratory examinations are carried out according to the procedures and&#xD;
      method by laboratories accredited in Guinea for the diagnosis of COVID19. Data is encoded,&#xD;
      entered and processed using statistical software.&#xD;
&#xD;
      The comparison between the three cohorts will be made using either the Anova test for&#xD;
      continuous variables or the chi-square test for categorical variables. The rate of change&#xD;
      over time of virologic clearance, fever and other symptoms values as well as the differences&#xD;
      for these rates between treatment arms will be tested using mixed-effects modeling.&#xD;
&#xD;
      The biological samples will be stored at the biobank of the National Institute of Public&#xD;
      Health of Guinea.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Virologic clearance of throat swabs or lower respiratory tract secretions</measure>
    <time_frame>day 3 to day 14</time_frame>
    <description>Virologic clearance from admission to discharge at days 3, 6 and 14</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>COVID-19 symptoms development</measure>
    <time_frame>day 1 to day 14</time_frame>
    <description>number of patients who developed fever, cough, and any other clinical sign typical of the disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>day 1 to day 14</time_frame>
    <description>number of participants who developed treatment-related adverse effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worsened condition</measure>
    <time_frame>day 1 to day 14</time_frame>
    <description>number of patients whose condition worsened on D14</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">231</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Hydroxychloroquine/Azythromycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quinquina/Azythromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive 3.5g tea bags of Cinchona/Stevia powder orally at the rate of 3 tea bags per day for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4plants/Azythromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Hydroxychloroquine/Azithromycine</intervention_name>
    <description>Dual treatment with Hydroxychloroquine and Azythromycin</description>
    <arm_group_label>Hydroxychloroquine/Azythromycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Quinquina-Stevia/Azythromycin</intervention_name>
    <description>Dual treatment with Quinquina/Stevia (3/0,5) and Azythromycin</description>
    <arm_group_label>Quinquina/Azythromycin</arm_group_label>
    <other_name>CILE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>4Plants/Azythromycin</intervention_name>
    <description>Dual treatment with 4 plant species drug and Azythromycin</description>
    <arm_group_label>4plants/Azythromycin</arm_group_label>
    <other_name>ACAR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible patients are adults with COVID-19 confirmed by a positive PCR (Polymerase&#xD;
             Chain Reaction) test and without symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any patient hypersensitive to hydroxychloroquine or under traditional herbal treatment&#xD;
             in the two weeks preceding inclusion,&#xD;
&#xD;
          -  any patient with other acute or chronic illnesses such as heart failure, arterial&#xD;
             hypertension, renal failure, hepatocellular failure, tuberculosis or unable to take&#xD;
             the oral treatment;&#xD;
&#xD;
          -  any patient for whom one of the treatments under study is contraindicated according to&#xD;
             the doctor's opinion.&#xD;
&#xD;
          -  pregnant women,&#xD;
&#xD;
          -  severe neurological manifestations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Saliou Sow</last_name>
    <role>Principal Investigator</role>
    <affiliation>Infectious Disease Department - Donka National Hospital Conakry Guinea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Cissé</last_name>
    <role>Study Chair</role>
    <affiliation>Faculté des Sciences et Techniques de Santé, Université GAN Conakry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mamadou A Baldé</last_name>
    <role>Study Director</role>
    <affiliation>Institute for Research and Development of Medicinal and Food Plants of Guinea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Support Centers of Donka, Kenien and Gbessia</name>
      <address>
        <city>Conakry</city>
        <zip>224</zip>
        <country>Guinea</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Guinea</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>12719004</PMID>
  </results_reference>
  <results_reference>
    <citation>Balde 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.</citation>
    <PMID>26900129</PMID>
  </results_reference>
  <results_reference>
    <citation>Balde 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.</citation>
    <PMID>20561931</PMID>
  </results_reference>
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    <citation>Camara 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.</citation>
    <PMID>31852507</PMID>
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    <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. No abstract available.</citation>
    <PMID>32145363</PMID>
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    <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):85. doi: 10.3390/microorganisms8010085.</citation>
    <PMID>31936284</PMID>
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    <citation>Ren JL, Zhang AH, Wang XJ. Corrigendum to &quot;Traditional Chinese medicine for COVID-19 treatment&quot; [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.</citation>
    <PMID>32222346</PMID>
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    <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.</citation>
    <PMID>31610260</PMID>
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    <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.</citation>
    <PMID>32170559</PMID>
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    <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):1874-7. Chinese.</citation>
    <PMID>16499032</PMID>
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    <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.</citation>
    <PMID>15366588</PMID>
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    <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. 2020 Apr;26(4):243-250. doi: 10.1007/s11655-020-3192-6. Epub 2020 Feb 17.</citation>
    <PMID>32065348</PMID>
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    <citation>Magassouba 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. Erratum In: J Ethnopharmacol. 2010 Apr 21;128(3):705-8.</citation>
    <PMID>17825510</PMID>
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    <citation>Mahase E. Covid-19: WHO declares pandemic because of &quot;alarming levels&quot; of spread, severity, and inaction. BMJ. 2020 Mar 12;368:m1036. doi: 10.1136/bmj.m1036. No abstract available.</citation>
    <PMID>32165426</PMID>
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    <citation>Traore MS, Balde MA, Diallo MS, Balde ES, Diane S, Camara A, Diallo A, Balde A, Keita A, Keita SM, Oulare K, Magassouba FB, Diakite I, Diallo A, Pieters L, Balde AM. Ethnobotanical survey on medicinal plants used by Guinean traditional healers in the treatment of malaria. J Ethnopharmacol. 2013 Dec 12;150(3):1145-53. doi: 10.1016/j.jep.2013.10.048. Epub 2013 Oct 31.</citation>
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    <citation>• WHO, 2013. WHO Traditional medicine strategy 2014-2023. https://www.who.int/medicines/publications/traditional/trm_strategy14_23/en/.</citation>
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    <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/s13643-020-01343-4.</citation>
    <PMID>32268923</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Treatment; clinical research</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
    <mesh_term>Hydroxychloroquine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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 ...</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data could be available from september 30th to december 30th</ipd_time_frame>
    <ipd_access_criteria>partnership framework established</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04501965
org study id: IRDPMAG
nct id: NCT04501965
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Treatment
masking: None (Open Label)
measure: Virologic clearance of throat swabs or lower respiratory tract secretions
time frame: day 3 to day 14
description: Virologic clearance from admission to discharge at days 3, 6 and 14
measure: COVID-19 symptoms development
time frame: day 1 to day 14
description: number of patients who developed fever, cough, and any other clinical sign typical of the disease
measure: Adverse effects
time frame: day 1 to day 14
description: number of participants who developed treatment-related adverse effects
measure: Worsened condition
time frame: day 1 to day 14
description: number of patients whose condition worsened on D14
arm group label: Hydroxychloroquine/Azythromycin
arm group type: Active Comparator
description: 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
arm group label: Quinquina/Azythromycin
arm group type: Experimental
description: Patients receive 3.5g tea bags of Cinchona/Stevia powder orally at the rate of 3 tea bags per day for 10 days
arm group label: 4plants/Azythromycin
arm group type: Experimental
description: 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
intervention type: Combination Product
intervention name: Hydroxychloroquine/Azithromycine
description: Dual treatment with Hydroxychloroquine and Azythromycin
arm group label: Hydroxychloroquine/Azythromycin
intervention type: Combination Product
intervention name: Quinquina-Stevia/Azythromycin
description: Dual treatment with Quinquina/Stevia (3/0,5) and Azythromycin
arm group label: Quinquina/Azythromycin
other name: CILE
intervention type: Combination Product
intervention name: 4Plants/Azythromycin
description: Dual treatment with 4 plant species drug and Azythromycin
arm group label: 4plants/Azythromycin
other name: ACAR
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Saliou Sow
role: Principal Investigator
affiliation: Infectious Disease Department - Donka National Hospital Conakry Guinea
last name: Mohamed Cissé
role: Study Chair
affiliation: Faculté des Sciences et Techniques de Santé, Université GAN Conakry
last name: Mamadou A Baldé
role: Study Director
affiliation: Institute for Research and Development of Medicinal and Food Plants of Guinea
facility: 
country: Guinea
citation: 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.
PMID: 12719004
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responsible party type: Sponsor
mesh term: COVID-19
mesh term: Azithromycin
mesh term: Hydroxychloroquine
sharing ipd: Yes
ipd description: 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 ...
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data could be available from september 30th to december 30th
ipd access criteria: partnership framework established