Changes to trial information |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Plan to share IPD |
08/04/2020 |
Regulatory requirement as pointed out by the reviewer |
No |
Yes |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD description |
08/04/2020 |
Regulatory requirement as pointed out by the reviewer |
|
Individual Participant Data that underlie the results of the study after deidentification |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD-Sharing time frame |
08/04/2020 |
Regulatory requirement as pointed out by the reviewer |
|
Beginning 9 months and ending 36 months after the publication of the study |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Key access criteria |
08/04/2020 |
Regulatory requirement as pointed out by the reviewer |
|
Outside investigators upon scientific review of the merits of their proposed research plan |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Study protocol document |
08/04/2020 |
Regulatory requirement as pointed out by the reviewer |
|
Study Protocol |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Official scientific title |
08/04/2020 |
edit |
A Single-Center, Single-blinded,
Randomized, Controlled Clinical Trial of the Safety and Efficacy of
Chloroquine Phosphate therapy and Hydroxychloroquine therapy compared to only Standard Support Therapy for the Treatment of COVID-19 in
Hospitalized Patients in Lagos State
|
A Single-Center, Single-blinded, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Chloroquine Phosphate therapy and Hydroxychloroquine therapy compared to only Standard Support Therapy for the Treatment of COVID-19 in Hospitalized Patients in Lagos State
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial description |
08/04/2020 |
edit |
The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread
globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses.
The overall aim of this study is to evaluate the clinical efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate relative to only standard supportive therapy among hospitalized adult patients who have COVID-19 in Nigeria. |
The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses. The overall aim of this study is to evaluate the clinical efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate relative to only standard supportive therapy among hospitalized adult patients who have COVID-19 in Nigeria. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Official scientific title |
08/04/2020 |
Protocol was updated |
A Single-Center, Single-blinded, Randomized, Controlled Clinical Trial of the Safety and Efficacy of Chloroquine Phosphate therapy and Hydroxychloroquine therapy compared to only Standard Support Therapy for the Treatment of COVID-19 in Hospitalized Patients in Lagos State
|
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Efficacy and Safety of Chloroquine Phosphate and Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients in Lagos State |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial description |
08/04/2020 |
Protocol was updated |
The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses. The overall aim of this study is to evaluate the clinical efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate relative to only standard supportive therapy among hospitalized adult patients who have COVID-19 in Nigeria. |
The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses. To evaluate the clinical efficacy of chloroquine phosphate and hydroxychloroquine sulphate added-on to standard therapy relative to standard therapy alone for treatment of patients hospitalized with COVID-19 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
08/04/2020 |
Protocol was updated |
Control Group, Placebo, , 10 days, white, film-coated tablets, 136, Placebo |
Control Group, Placebo, , 10 days, white, film-coated tablets, 200, Placebo |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
08/04/2020 |
Protocol was updated |
Experimental Group, Chloroquine phosphate, 500mg bd, 10 days, white, film-coated tablets, 136, |
Experimental Group, Chloroquine phosphate, 500mg bd, 10 days, white, film-coated tablets, 200, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
08/04/2020 |
Protocol was updated |
Experimental Group, Hydroxychloroquine sulphate, 400mg bd, 10 days, white, film-coated tablets, 136, |
Experimental Group, Hydroxychloroquine sulphate, 400mg bd, 10 days, white, film-coated tablets, 200, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Contact People |
Contacs List |
08/04/2020 |
Full first name written |
Scientific Enquiries, Sam, Anya, Dr., sea.anya@gmail.com, , +2347056416162, Plot 154 Aguiyi Ironsi Layout, Umuahia, 23401, Nigeria, Independent Consultant |
Scientific Enquiries, Samuel, Anya, Dr., sea.anya@gmail.com, , +2347056416162, Plot 154 Aguiyi Ironsi Layout, Umuahia, 23401, Nigeria, Independent Consultant |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Official scientific title |
22/06/2020 |
Protocol upgrade. Additional arm, sites. |
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Efficacy and Safety of Chloroquine Phosphate and Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients in Lagos State |
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Efficacy and Safety of Chloroquine Phosphate, Hydroxychloroquine sulphate and Lopinavir/Ritonavir for the Treatment of COVID-19 in Lagos State.
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial description |
22/06/2020 |
Protocol upgrade. Additional arm, sites. |
The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses. To evaluate the clinical efficacy of chloroquine phosphate and hydroxychloroquine sulphate added-on to standard therapy relative to standard therapy alone for treatment of patients hospitalized with COVID-19 |
The novel severe acute respiratory syndrome corona virus 2, now known as SARS-COV-2, has spread globally since first detected in Wuhan China, in December 2019. This novel coronavirus-SARS-CoV-2, and the disease caused by this virus has been designated COVID-19. Currently there are no approved therapeutic agents available for coronaviruses.
To evaluate the clinical efficacy and safety of therapeutic agents in the treatment of adults with lab positive COVID-19 in Lagos State: All study subjects will receive standard therapy with the following add-ons: Arm 1 - chloroquine phosphate; Arm 2 – hydroxychloroquine sulphate; Arm 3 – Lopinavir/ ritonavir and Arm 4 – placebo. There will be interim monitoring to allow early stopping for futility,
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Anticipated trial start date |
22/06/2020 |
Protocol upgrade. Additional arm, sites. |
17 Apr 2020 |
20 Apr 2020 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Actual trial start date |
22/06/2020 |
Protocol upgrade. Additional arm, sites. |
|
15 Jun 2020 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Anticipated date of last follow up |
22/06/2020 |
Protocol upgrade. Additional arm, sites. |
16 Oct 2020 |
16 Dec 2020 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Completion date |
22/06/2020 |
Protocol upgrade. Additional arm, sites. |
|
15 Jan 2021 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Target no of participants |
22/06/2020 |
Protocol upgrade. Additional arm, sites. |
600 |
800 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
22/06/2020 |
Trial started |
Not yet recruiting |
Recruiting |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Masking / blinding |
22/06/2020 |
Protocol upgrade. Additional arm, sites. |
Care giver/Provider, Participants |
Outcome Assessors, Care giver/Provider, Participants |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
22/06/2020 |
protocol upgrade. Additional arm, sites. |
|
Experimental Group, LopinavirRitonavir, 400mg/100mg bd
, 14, yellow, film-coated, 200, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Recruitment Centre |
RecruitmentCentre List |
22/06/2020 |
Additional site |
|
Onikan Stadium Isolation Centre, Tafawa Balewa Square, Lagos, , Nigeria |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Recruitment Centre |
RecruitmentCentre List |
22/06/2020 |
Additional site |
|
EtiOsa Landmark Isolation Centre, Water Corporation Drive, Victoria Island, Lagos, , Nigeria |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Recruitment Centre |
RecruitmentCentre List |
22/06/2020 |
Additional site |
|
Lekki Isolation Centre, Opposite Mega Chicken, Lagos, , Nigeria |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Recruitment Centre |
RecruitmentCentre List |
22/06/2020 |
Additional site |
|
General Hospital Gbagada, 1, Hospital Road, Gbagada, Lagos, , Nigeria |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Recruitment Centre |
RecruitmentCentre List |
22/06/2020 |
Additional site |
|
Lagos State University Teaching Hospital, 1, Oba Akinjobi Way, Ikeja GRA, Ikeja, , Nigeria |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Ethics |
Ethics List |
22/06/2020 |
Protocol upgrade. Additional arm, sites |
|
TRUE, LASUTH Health Research Ethics Committee, 1, Oba Akinjobi Way, Ikeja, Ikeja, 23401, Nigeria, , 22 May 2020, 014710670, dcst@lasuth.org, 10928_11476_4737.pdf |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
06/07/2020 |
Error in previous info entry |
|
Experimental Group, Chloroquine phosphate, 500mg bd, 7 days, white, film-coated tablets, 200, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
06/07/2020 |
Error in previous info entry |
Experimental Group, Hydroxychloroquine sulphate, 400mg bd, 10 days, white, film-coated tablets, 200, |
Experimental Group, Hydroxychloroquine sulphate, 400mg bd, 7 days, white, film-coated tablets, 200, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
06/07/2020 |
Incomplete previous entry |
|
Control Group, Chloroquine Placebo, 2 tablets twice daily, 7 days, white, film-coated tablets, 200, Placebo |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
06/07/2020 |
Incomplete previous entry |
|
Control Group, Hydroxychloroquine placebo, 2 tablets twice daily, 7 days, white, film-coated tablets, 600, Placebo |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
06/07/2020 |
Updated info |
Control Group, Chloroquine Placebo, 2 tablets twice daily, 7 days, white, film-coated tablets, 200, Placebo |
Control Group, Chloroquine Placebo, 2 tablets twice daily, 7 days, white, film-coated tablets, 600, Placebo |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
06/07/2020 |
Incomplete previous info |
|
Control Group, LopinavirRitonavir placebo, 2 tablets twice daily, 14 days, yellow, film-coated tablets, 600, Placebo |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Recruitment status |
08/10/2021 |
Update |
Recruiting |
Stopped early/ terminated |