| Changes to trial information |
|
Section Name
|
Field Name
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Date
|
Reason
|
Old Value
|
Updated Value
|
| Trial Information |
Actual trial start date |
07/10/2020 |
Unexpected delays on Study Operational Activities |
|
15 Sep 2020 |
|
Section Name
|
Field Name
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Date
|
Reason
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Old Value
|
Updated Value
|
| Trial Information |
Anticipated date of last follow up |
10/05/2022 |
updates |
31 Dec 2021 |
30 Sep 2022 |
|
Section Name
|
Field Name
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Date
|
Reason
|
Old Value
|
Updated Value
|
| Trial Information |
Completion date |
03/05/2024 |
updated date |
|
21 Dec 2022 |
|
Section Name
|
Field Name
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Date
|
Reason
|
Old Value
|
Updated Value
|
| Trial Information |
Final no of participants |
24/06/2020 |
We are targeting a number of patients between 2000 and 3000 patients. As it is not possible to enter this information. I am adding the average 2500
|
|
2500 |
|
Section Name
|
Field Name
|
Date
|
Reason
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Old Value
|
Updated Value
|
| Trial Information |
Final no of participants |
24/06/2020 |
We are targeting a number of patients between 2000 and 3000 patients with 3 to 4 arms of randomisation. As it is not possible to enter this information. I am entering the closest number to this estimation. thanks
|
2500 |
2800 |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Trial Information |
Final no of participants |
03/05/2024 |
updated number |
2800 |
1942 |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Trial Information |
Recruitment status |
22/09/2020 |
start recruitment |
Not yet recruiting |
Recruiting |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Trial Information |
Recruitment status |
03/05/2024 |
updated status |
Recruiting |
Completed |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Eligibility |
Inclusion criteria |
07/10/2020 |
updated in the protocol |
1. Male or female patients,
2. Adults > or= 18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis.
3. COVID-19 confirmed by molecular biology for SARS-Cov2 according to national guidelines, based on result within 24 hours prior to screening.
4. Viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) > or= 94%.
5. Corrected QT interval (QTc - Fridericia) < 500 msec on ECG.
6. Signed written consent from the patient or his/her representative.
7. Accepting and having the ability to be reached by telephone throughout the study.
8. Having designated a contact person who can be contacted in case of emergency.
|
1. Male or female patients,
2. Adults > or= 18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis.
3. COVID-19 confirmed by molecular biology for SARS-Cov2 according to national guidelines, based on result within 24 hours prior to screening.
4. Viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) > or= 94%.
5. Corrected QT interval (QTc - Fridericia) < 480 msec on ECG.
6. Signed written consent from the patient or his/her representative.
7. Accepting and having the ability to be reached by telephone throughout the study.
8. Having designated a contact person who can be contacted in case of emergency.
|
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Eligibility |
Inclusion criteria |
07/09/2021 |
Update due to removal of HCQ and Lopi /Rito, and addition of new arms |
1. Male or female patients,
2. Adults > or= 18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis.
3. COVID-19 confirmed by molecular biology for SARS-Cov2 according to national guidelines, based on result within 24 hours prior to screening.
4. Viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) > or= 94%.
5. Corrected QT interval (QTc - Fridericia) < 480 msec on ECG.
6. Signed written consent from the patient or his/her representative.
7. Accepting and having the ability to be reached by telephone throughout the study.
8. Having designated a contact person who can be contacted in case of emergency.
|
1. Male or female patients,
2. Adults > or= 18 years of age at the time of screening. Children > 12 years of age may be included if recommended by the DSMB after the first analysis.
3. COVID-19 confirmed by molecular biology or validated antigenic test available in the country for SARS-Cov2 according to national guidelines, based on result within 24 hours prior to screening.
4. Viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) > or= 94%.
5. Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms
6. Signed written consent from the patient or his/her representative.
7. Accepting and having the ability to be reached by telephone throughout the study.
8. Having designated a contact person who can be contacted in case of emergency.
|
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Eligibility |
Exclusion criteria |
07/10/2020 |
updated in the protocol |
1. Abnormal physical examination findings:
• respiratory rate > or= 25 per minute;
• blood pressure < 90/60 mmHg or > 160/100 mmHg;
• body weight < 45 kg for patients > or= 18 years of age and age-adapted for children > 12 years of age if inclusion is recommended by the DSMB after the first analysis;
• recurrent diarrhoea or vomiting episodes (> 3 in the last 24 hours) or hypokalaemia (< 3.5 mmol/L) or hyperkalaemia (> 5 mmol/L).
2. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
3. Feeling unwell for more than 7 days prior to screening.
4. Severe cardiopathy or history of arrhythmia, renal or liver insufficiency.
5. History of congenital or acquired long QT-interval, family history of long QT arrythmia, cardiac disease such as heart failure, myocardial infarction, family history of sudden cardiac death, sudden cardiac death, bradycardia < 50 bpm.
6. Past history of retinopathy, such as spots or dark strings floating in the field of vision (floaters), blurred or fluctuating vision, impaired colour vision, dark or empty areas in vision.
7. History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
8. End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months.
9. Known pregnancy or breast-feeding, unless recommended by the Data and Safety Monitoring Board after the first interim analysis.
10. Prior treatment with. lopinavir/ritonavir within 29 days prior to screening except if patients are receiving the same regimen as planned in this study. Patients randomised to lopinavir/ritonavir will stop their current treatment and switch to the IP lopinavir/ ritonavir. If randomised to other arms, patients will continue their current treatment with lopinavir/ritonavir.
11. Prior treatment with hydroxychloroquine within 29 days prior to screening or on-going at screening.
12. Use of concomitant medications that are contraindicated |
1. Abnormal physical examination findings:
• respiratory rate > or= 25 per minute;
• blood pressure < 90/60 mmHg or > 160/100 mmHg;
• body weight < 45 kg for patients > or= 18 years of age and age-adapted for children > 12 years of age if inclusion is recommended by the DSMB after the first analysis;
• recurrent diarrhoea or vomiting episodes (> 3 in the last 24 hours) or hypokalaemia (< 3.5 mmol/L).
2. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
3. Feeling unwell for more than 7 days prior to screening.
4. Severe cardiopathy or history of arrhythmia, renal or liver insufficiency.
5. History of congenital or acquired long QT-interval, family history of long QT arrythmia, cardiac disease such as heart failure, myocardial infarction, family history of sudden cardiac death, sudden cardiac death, bradycardia < 50 bpm.
6. Past history of retinopathy, such as spots or dark strings floating in the field of vision (floaters), blurred or fluctuating vision, impaired colour vision, dark or empty areas in vision.
7. History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
8. End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months.
9. Known pregnancy or breast-feeding, unless recommended by the Data and Safety Monitoring Board after the first interim analysis.
10. Prior treatment with. lopinavir/ritonavir within 29 days prior to screening except if patients are receiving the same regimen as planned in this study. Patients randomised to lopinavir/ritonavir will stop their current treatment and switch to the IP lopinavir/ ritonavir. If randomised to other arms, patients will continue their current treatment with lopinavir/ritonavir.
11. Prior treatment with hydroxychloroquine within 29 days prior to screening or on-going at screening.
12. Use of concomitant medications that are contraindicated |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Eligibility |
Exclusion criteria |
07/09/2021 |
Update due to removal of HCQ and Lopi /Rito, and addition of new arms |
1. Abnormal physical examination findings:
• respiratory rate > or= 25 per minute;
• blood pressure < 90/60 mmHg or > 160/100 mmHg;
• body weight < 45 kg for patients > or= 18 years of age and age-adapted for children > 12 years of age if inclusion is recommended by the DSMB after the first analysis;
• recurrent diarrhoea or vomiting episodes (> 3 in the last 24 hours) or hypokalaemia (< 3.5 mmol/L).
2. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
3. Feeling unwell for more than 7 days prior to screening.
4. Severe cardiopathy or history of arrhythmia, renal or liver insufficiency.
5. History of congenital or acquired long QT-interval, family history of long QT arrythmia, cardiac disease such as heart failure, myocardial infarction, family history of sudden cardiac death, sudden cardiac death, bradycardia < 50 bpm.
6. Past history of retinopathy, such as spots or dark strings floating in the field of vision (floaters), blurred or fluctuating vision, impaired colour vision, dark or empty areas in vision.
7. History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
8. End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months.
9. Known pregnancy or breast-feeding, unless recommended by the Data and Safety Monitoring Board after the first interim analysis.
10. Prior treatment with. lopinavir/ritonavir within 29 days prior to screening except if patients are receiving the same regimen as planned in this study. Patients randomised to lopinavir/ritonavir will stop their current treatment and switch to the IP lopinavir/ ritonavir. If randomised to other arms, patients will continue their current treatment with lopinavir/ritonavir.
11. Prior treatment with hydroxychloroquine within 29 days prior to screening or on-going at screening.
12. Use of concomitant medications that are contraindicated |
1. Abnormal physical examination findings:
• respiratory rate > or= 25 per minute;
• blood pressure < 90/60 mmHg or > 160/100 mmHg;
• body weight < 45 kg for patients > or= 18 years of age and age-adapted for children > 12 years of age if inclusion is recommended by the DSMB after the first analysis;
• recurrent diarrhoea or vomiting episodes (> 3 in the last 24 hours) or hypokalaemia (< 3.5 mmol/L).
2 Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms
3. Feeling unwell for more than 7 days prior to screening.
4 to 7 Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms
8. End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months.
9.-13 Criteria removed due to removal of HCQ and Lopinavir/Ritonavir arms
14. On-going treatment at screening with:
• chronic systemic glucocorticosteroid > 40 mg daily;
• immunosuppressive treatment;
15. For any new antiviral included in the study, prior treatment with the antiviral, presence of contraindication to its use or intake of concomitant medication proscribed with its use.
16. Unwilling or unable to comply with the requirements of the study protocol at any time during the study, e.g. no access to or not comfortable with use of a smartphone or with answering questions using a telephone, in the opinion of the Investigator or cannot use an inhalation chamber.
17. Any other reason that makes it impossible to monitor the patient during the study.
18. Enrolled in other clinical trials with unregistered drugs or with registered drug which could interact with any of the study IPs or contra-indicated as concomitant treatment within the past 3 months prior screening.
19. Known pulmonary arterial hypertension (PAH) or fibrosis.
20. Use of concomitant medications that are contraindicated with ciclesonide, known hypersensitivity to ciclesonide or any other ingredient in the formulation.
21........ |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Eligibility |
Age group |
23/06/2020 |
edit to include the full age range |
Adult: 19 Year-44 Year |
Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Intervention |
Intervention List |
07/09/2021 |
Arm stopped |
Experimental Group, Lopinavir Ritonavir, Daily intake of lopinavir 800 mg / ritonavir 200 mg, 14 days, Two tablets twice daily for a total daily intake of lopinavir 800 mg / ritonavir 200 mg, 700, |
Experimental Group, Lopinavir Ritonavir ARM STOPPED, Daily intake of lopinavir 800 mg / ritonavir 200 mg, 14 days, Two tablets twice daily for a total daily intake of lopinavir 800 mg / ritonavir 200 mg
ARM STOPPED, 700, |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Intervention |
Intervention List |
07/09/2021 |
Arm stopped |
Experimental Group, Hydroxychloroquine, Day 1: loading dose of 800 mg
Day 2-7: maintenance dose of 400 mg daily, 7 days, Day 1: loading dose of 800 mg daily, divided into two daily intakes of 400 mg taken 12 hours apart
Day 2-7: maintenance dose of 400 mg daily, divided into two daily intakes of 200 mg taken 12 hours apart
, 700, |
Experimental Group, Hydroxychloroquine ARM STOPPED, Day 1: loading dose of 800 mg
Day 2-7: maintenance dose of 400 mg daily, 7 days, Day 1: loading dose of 800 mg daily, divided into two daily intakes of 400 mg taken 12 hours apart
Day 2-7: maintenance dose of 400 mg daily, divided into two daily intakes of 200 mg taken 12 hours apart
ARM STOPPED, 700, |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Intervention |
Intervention List |
24/06/2020 |
To reflect the maximum number of patients |
|
Experimental Group, To be determined, To be determined, To be determined, In the protocol we have considered the option to add a fourth arm if a new treatment is available, 700, |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Intervention |
Intervention List |
07/09/2021 |
update |
Experimental Group, To be determined, To be determined, To be determined, In the protocol we have considered the option to add a fourth arm if a new treatment is available, 700, |
Experimental Group, Nitazoxanide and Ciclesonide, Nitazoxanide: Oral route, 2000 mg nitazoxanide daily, divided into two daily intakes of two tablets of nitazoxanide 500 mg taken 12 hours apart with a meal
Ciclesonide: Oral inhalation with inhalation chamber, 320 mcg BID per day, 14 days, In the protocol we have considered the option to add additional arm if a new treatment is available, 700, |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Intervention |
Intervention List |
07/09/2021 |
new treatment arm added to the protocol |
|
Experimental Group, Ivermectin and Amodiaquine Artesunate , Ivermectin (IVM): Oral route, Daily single dose according to body weight: 0,4 mg/kg in fasted condition
Artesunate Amodiaquine (ASAQ): Oral route, 200 mg artesunate and 540 mg amodiaquine daily, two tablets of 100 mg of artesunate and 270 mg of amodiaquine , ASAQ: 3 days
IVM: 5 days, additional interventional arm, 700, |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Intervention |
Intervention List |
10/05/2022 |
new treatment arm added |
|
Experimental Group, Fluoxetine and Budesonide , Fluoxetine: 40 mg per day, once a day with two capsules of fluoxetin 20 mg
Budesonide: 400 mcg BID per day, 7 days, During 7 days:
Fluoxetine: 40 mg per day, once a day with two capsules of fluoxetin 20 mg
Budesonide: 400 mcg BID per day, 700, |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Ethics |
Ethics List |
07/10/2020 |
Approval received |
FALSE, Ethics Committee for Research in Health, Ministere de la Sante Building Lamizana Ouagadougou, Ouagadougou, 0970099, Burkina Faso, 19 Jun 2020, , 22650324159, ouedd@yahoo.fr, |
TRUE, Ethics Committee for Research in Health, Ministere de la Sante Building Lamizana Ouagadougou, Ouagadougou, 0970099, Burkina Faso, 19 Jun 2020, 12 Aug 2020, 22650324159, ouedd@yahoo.fr, 12150_11462_4737.pdf |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Ethics |
Ethics List |
07/10/2020 |
received approval |
FALSE, Comite National Ethique de la Sante, Local 5 1er niveau, Immeuble PNMLS Kasa-Vubu, Kinshasa, 3089, Democratic Republic of the Congo, 19 Jun 2020, , 00243998419816, feli1munday@yahoo.fr, |
TRUE, Comite National Ethique de la Sante, Local 5 1er niveau, Immeuble PNMLS Kasa-Vubu, Kinshasa, 3089, Democratic Republic of the Congo, 19 Jun 2020, 21 Jul 2020, 00243998419816, feli1munday@yahoo.fr, 12150_11464_4737.pdf |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Funding Source |
FundingSources List |
24/06/2020 |
ANTICOV study is sponsored by a consortium of 9 Sponsors. Several grants were submitted but for now we have not yet received a formal answer on the approval. |
|
DNDi, 15 Chemin Louis DUnant, Geneve, 1202, Switzerland, Self Funded, |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Contact People |
Contacs List |
06/10/2020 |
new email address and phone number |
Public Enquiries, James, Arkinstall, Mr., jarkinstall@dndi.org, , 0041793929823, 15 chemin louis Dunant, Geneve, 1202, Switzerland, Head of Communications and Advocacy |
Public Enquiries, James, Arkinstall, Mr., media@dndi.org, , 0041229069230, 15 chemin louis Dunant, Geneve, 1202, Switzerland, Head of Communications and Advocacy |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
Plan to share IPD |
24/06/2020 |
Reflect the intent of the ANTICOV consortium to share outcome of this study |
Undecided |
Yes |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
IPD description |
24/06/2020 |
Reflect the intent of the ANTICOV consortium to share outcome of this study |
|
The intent is to have summary of results available on an open access website |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
IPD description |
10/05/2022 |
updates |
The intent is to have summary of results available on an open access website |
The intent is to have summary of results available on an open access website
As of 22 February 2022, the combined treatment arm nitazoxanide/ciclesonide has been stopped for futility |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
IPD description |
10/05/2022 |
updates |
The intent is to have summary of results available on an open access website
As of 22 February 2022, the combined treatment arm nitazoxanide/ciclesonide has been stopped for futility |
The intent is to have summary of results available on an open access website: please see regular updates below:
January 2021: Hydroxychloroquine and Lopinavir/Ritonavir arms were stopped folloming release of WHO Guidelines and recommendations of the ANTICOV DSMB
As of 22 February 2022, the combined treatment arm nitazoxanide/ciclesonide has been stopped for futility |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
IPD-Sharing time frame |
24/06/2020 |
Reflect the intent of the ANTICOV consortium to share outcome of this study |
|
within 12 months of the study completion |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
Key access criteria |
24/06/2020 |
Reflect the intent of the ANTICOV consortium to share outcome of this study |
|
open |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
IPD URL |
24/06/2020 |
Reflect the intent of the ANTICOV consortium to share outcome of this study |
|
to be determined |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
IPD URL |
10/05/2022 |
added the URL |
to be determined |
https://anticov.org/ |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
Study protocol document |
24/06/2020 |
Reflect the intent of the ANTICOV consortium to share outcome of this study |
|
Study Protocol |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
Results Available |
03/05/2024 |
CSR available |
No |
Yes |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
Result Summary Pdf file1 |
03/05/2024 |
CSR available |
|
12150_10418_1045.pdf |