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Case Study

COVID-19 Case Study: Monitoring Patients Remotely Using Digital Devices

Infectious Disease
Download the PDF

Challenge

Because the patients in this study were experiencing symptoms associated with COVID-19, RedHill Biopharma sought to reduce participant burden as much as possible. The sponsor recognized that site and clinic visits would not only be a nuisance for ill patients but would also expose healthcare staff to the risk of contracting the virus. However, the seriousness of the virus—in addition to its largely enigmatic status at the time—necessitated a high degree of clinical oversight.

RedHill’s study required:

1. The ability to recruit patients in the geographic areas where COVID-19 was spiking.

2. The monitoring of patients’ vitals for both efficacy and safety tracking.

3. Assessments by clinicians.

‍

Solution

ObvioHealth designed a remote study using a combination of home health visits, digital monitoring devices, and ePRO.

Recruitment

The study was conducted in both the U.S. and South Africa. To accelerate recruitment, ObvioHealth employed digital strategies—built into the decentralized design of the study—to identify COVID-19 hot spots and recruit swiftly in those designated areas. Enrollment occurred on-site, where the patients consented and were trained on proper device usage.

Digital Monitoring Devices

Patients used three remote monitoring devices at home to capture vitals and other measures, including temperature, oxygen saturation, and ECG. The data points from these devices were transferred directly into ObvioHealth’s system, where they were closely monitored for any irregularities.

Health Visits

Patients were given the option of either home health visits or on-site visits. These visits included blood sample collection and PCR swabs.

ePRO

Using ObvioHealth’s app, patients recorded their symptoms daily for the first four weeks and then three times per week for the remaining four weeks.

‍

Results

RedHill Biopharma followed patients daily for two months, collecting vital signs that were imperative to the study’s endpoints. Data collection of this magnitude would not have been possible within the strictures of a traditional, in-person trial.  
‍
The successful study endpoints achieved in early 2022 empowered RedHill Biopharma with the data needed to initiate discussions with regulators.

‍

Testimonial

When glitches arose, as would be expected in a novel situation such as this, the ObvioHealth team was available to work through the problems and correct them for subsequent patient entry. I’d feel very comfortable recommending ObvioHealth.

Dr. Terry Plasse
Medical Director at RedHill Biopharma

‍

Case Study

COVID-19 Case Study: Monitoring Patients Remotely Using Digital Devices

Infectious Disease
Download the PDF

100%

reduction in hospitalizations due to COVID-19

87.80%

reduction in reported new severe COVID-19 symptoms

Challenge

Because the patients in this study were experiencing symptoms associated with COVID-19, RedHill Biopharma sought to reduce participant burden as much as possible. The sponsor recognized that site and clinic visits would not only be a nuisance for ill patients but would also expose healthcare staff to the risk of contracting the virus. However, the seriousness of the virus—in addition to its largely enigmatic status at the time—necessitated a high degree of clinical oversight.

RedHill’s study required:

1. The ability to recruit patients in the geographic areas where COVID-19 was spiking.

2. The monitoring of patients’ vitals for both efficacy and safety tracking.

3. Assessments by clinicians.

‍

Solution

ObvioHealth designed a remote study using a combination of home health visits, digital monitoring devices, and ePRO.

Recruitment

The study was conducted in both the U.S. and South Africa. To accelerate recruitment, ObvioHealth employed digital strategies—built into the decentralized design of the study—to identify COVID-19 hot spots and recruit swiftly in those designated areas. Enrollment occurred on-site, where the patients consented and were trained on proper device usage.

Digital Monitoring Devices

Patients used three remote monitoring devices at home to capture vitals and other measures, including temperature, oxygen saturation, and ECG. The data points from these devices were transferred directly into ObvioHealth’s system, where they were closely monitored for any irregularities.

Health Visits

Patients were given the option of either home health visits or on-site visits. These visits included blood sample collection and PCR swabs.

ePRO

Using ObvioHealth’s app, patients recorded their symptoms daily for the first four weeks and then three times per week for the remaining four weeks.

‍

Results

RedHill Biopharma followed patients daily for two months, collecting vital signs that were imperative to the study’s endpoints. Data collection of this magnitude would not have been possible within the strictures of a traditional, in-person trial.  
‍
The successful study endpoints achieved in early 2022 empowered RedHill Biopharma with the data needed to initiate discussions with regulators.

‍

Testimonial

When glitches arose, as would be expected in a novel situation such as this, the ObvioHealth team was available to work through the problems and correct them for subsequent patient entry. I’d feel very comfortable recommending ObvioHealth.

Dr. Terry Plasse
Medical Director at RedHill Biopharma

‍

Case Study

COVID-19 Case Study: Monitoring Patients Remotely Using Digital Devices

Infectious Disease
Download the PDF

Challenge

Because the patients in this study were experiencing symptoms associated with COVID-19, RedHill Biopharma sought to reduce participant burden as much as possible. The sponsor recognized that site and clinic visits would not only be a nuisance for ill patients but would also expose healthcare staff to the risk of contracting the virus. However, the seriousness of the virus—in addition to its largely enigmatic status at the time—necessitated a high degree of clinical oversight.

RedHill’s study required:

1. The ability to recruit patients in the geographic areas where COVID-19 was spiking.

2. The monitoring of patients’ vitals for both efficacy and safety tracking.

3. Assessments by clinicians.

‍

Solution

ObvioHealth designed a remote study using a combination of home health visits, digital monitoring devices, and ePRO.

Recruitment

The study was conducted in both the U.S. and South Africa. To accelerate recruitment, ObvioHealth employed digital strategies—built into the decentralized design of the study—to identify COVID-19 hot spots and recruit swiftly in those designated areas. Enrollment occurred on-site, where the patients consented and were trained on proper device usage.

Digital Monitoring Devices

Patients used three remote monitoring devices at home to capture vitals and other measures, including temperature, oxygen saturation, and ECG. The data points from these devices were transferred directly into ObvioHealth’s system, where they were closely monitored for any irregularities.

Health Visits

Patients were given the option of either home health visits or on-site visits. These visits included blood sample collection and PCR swabs.

ePRO

Using ObvioHealth’s app, patients recorded their symptoms daily for the first four weeks and then three times per week for the remaining four weeks.

‍

Results

RedHill Biopharma followed patients daily for two months, collecting vital signs that were imperative to the study’s endpoints. Data collection of this magnitude would not have been possible within the strictures of a traditional, in-person trial.  
‍
The successful study endpoints achieved in early 2022 empowered RedHill Biopharma with the data needed to initiate discussions with regulators.

‍

Testimonial

When glitches arose, as would be expected in a novel situation such as this, the ObvioHealth team was available to work through the problems and correct them for subsequent patient entry. I’d feel very comfortable recommending ObvioHealth.

Dr. Terry Plasse
Medical Director at RedHill Biopharma

‍

Case Study

COVID-19 Case Study: Monitoring Patients Remotely Using Digital Devices

Infectious Disease
Download the PDF

Challenge

Because the patients in this study were experiencing symptoms associated with COVID-19, RedHill Biopharma sought to reduce participant burden as much as possible. The sponsor recognized that site and clinic visits would not only be a nuisance for ill patients but would also expose healthcare staff to the risk of contracting the virus. However, the seriousness of the virus—in addition to its largely enigmatic status at the time—necessitated a high degree of clinical oversight.

RedHill’s study required:

1. The ability to recruit patients in the geographic areas where COVID-19 was spiking.

2. The monitoring of patients’ vitals for both efficacy and safety tracking.

3. Assessments by clinicians.

‍

Solution

ObvioHealth designed a remote study using a combination of home health visits, digital monitoring devices, and ePRO.

Recruitment

The study was conducted in both the U.S. and South Africa. To accelerate recruitment, ObvioHealth employed digital strategies—built into the decentralized design of the study—to identify COVID-19 hot spots and recruit swiftly in those designated areas. Enrollment occurred on-site, where the patients consented and were trained on proper device usage.

Digital Monitoring Devices

Patients used three remote monitoring devices at home to capture vitals and other measures, including temperature, oxygen saturation, and ECG. The data points from these devices were transferred directly into ObvioHealth’s system, where they were closely monitored for any irregularities.

Health Visits

Patients were given the option of either home health visits or on-site visits. These visits included blood sample collection and PCR swabs.

ePRO

Using ObvioHealth’s app, patients recorded their symptoms daily for the first four weeks and then three times per week for the remaining four weeks.

‍

Results

RedHill Biopharma followed patients daily for two months, collecting vital signs that were imperative to the study’s endpoints. Data collection of this magnitude would not have been possible within the strictures of a traditional, in-person trial.  
‍
The successful study endpoints achieved in early 2022 empowered RedHill Biopharma with the data needed to initiate discussions with regulators.

‍

Testimonial

When glitches arose, as would be expected in a novel situation such as this, the ObvioHealth team was available to work through the problems and correct them for subsequent patient entry. I’d feel very comfortable recommending ObvioHealth.

Dr. Terry Plasse
Medical Director at RedHill Biopharma

‍

Case Study

COVID-19 Case Study: Monitoring Patients Remotely Using Digital Devices

Infectious Disease
Download the PDF

Challenge

Because the patients in this study were experiencing symptoms associated with COVID-19, RedHill Biopharma sought to reduce participant burden as much as possible. The sponsor recognized that site and clinic visits would not only be a nuisance for ill patients but would also expose healthcare staff to the risk of contracting the virus. However, the seriousness of the virus—in addition to its largely enigmatic status at the time—necessitated a high degree of clinical oversight.

RedHill’s study required:

1. The ability to recruit patients in the geographic areas where COVID-19 was spiking.

2. The monitoring of patients’ vitals for both efficacy and safety tracking.

3. Assessments by clinicians.

‍

Solution

ObvioHealth designed a remote study using a combination of home health visits, digital monitoring devices, and ePRO.

Recruitment

The study was conducted in both the U.S. and South Africa. To accelerate recruitment, ObvioHealth employed digital strategies—built into the decentralized design of the study—to identify COVID-19 hot spots and recruit swiftly in those designated areas. Enrollment occurred on-site, where the patients consented and were trained on proper device usage.

Digital Monitoring Devices

Patients used three remote monitoring devices at home to capture vitals and other measures, including temperature, oxygen saturation, and ECG. The data points from these devices were transferred directly into ObvioHealth’s system, where they were closely monitored for any irregularities.

Health Visits

Patients were given the option of either home health visits or on-site visits. These visits included blood sample collection and PCR swabs.

ePRO

Using ObvioHealth’s app, patients recorded their symptoms daily for the first four weeks and then three times per week for the remaining four weeks.

‍

Results

RedHill Biopharma followed patients daily for two months, collecting vital signs that were imperative to the study’s endpoints. Data collection of this magnitude would not have been possible within the strictures of a traditional, in-person trial.  
‍
The successful study endpoints achieved in early 2022 empowered RedHill Biopharma with the data needed to initiate discussions with regulators.

‍

Testimonial

When glitches arose, as would be expected in a novel situation such as this, the ObvioHealth team was available to work through the problems and correct them for subsequent patient entry. I’d feel very comfortable recommending ObvioHealth.

Dr. Terry Plasse
Medical Director at RedHill Biopharma

‍

Case Study

COVID-19 Case Study: Monitoring Patients Remotely Using Digital Devices

ObvioHealth successfully conducted a clinical trial for RedHill Biopharma to test the safety and efficacy of an oral medication for the treatment of COVID-19 symptoms. We designed this decentralized study to be conducted where the majority of patients recover from illness—in their homes. When the trial was launched in 2021, its unique combination of home health visits, electronic patient-reported outcomes (ePRO), and remote monitoring devices was pioneering—COVID-19 studies were typically conducted inside hospitals.

Infectious Disease
Download the PDF

Challenge

Because the patients in this study were experiencing symptoms associated with COVID-19, RedHill Biopharma sought to reduce participant burden as much as possible. The sponsor recognized that site and clinic visits would not only be a nuisance for ill patients but would also expose healthcare staff to the risk of contracting the virus. However, the seriousness of the virus—in addition to its largely enigmatic status at the time—necessitated a high degree of clinical oversight.

RedHill’s study required:

1. The ability to recruit patients in the geographic areas where COVID-19 was spiking.

2. The monitoring of patients’ vitals for both efficacy and safety tracking.

3. Assessments by clinicians.

‍

Solution

ObvioHealth designed a remote study using a combination of home health visits, digital monitoring devices, and ePRO.

Recruitment

The study was conducted in both the U.S. and South Africa. To accelerate recruitment, ObvioHealth employed digital strategies—built into the decentralized design of the study—to identify COVID-19 hot spots and recruit swiftly in those designated areas. Enrollment occurred on-site, where the patients consented and were trained on proper device usage.

Digital Monitoring Devices

Patients used three remote monitoring devices at home to capture vitals and other measures, including temperature, oxygen saturation, and ECG. The data points from these devices were transferred directly into ObvioHealth’s system, where they were closely monitored for any irregularities.

Health Visits

Patients were given the option of either home health visits or on-site visits. These visits included blood sample collection and PCR swabs.

ePRO

Using ObvioHealth’s app, patients recorded their symptoms daily for the first four weeks and then three times per week for the remaining four weeks.

‍

Results

RedHill Biopharma followed patients daily for two months, collecting vital signs that were imperative to the study’s endpoints. Data collection of this magnitude would not have been possible within the strictures of a traditional, in-person trial.  
‍
The successful study endpoints achieved in early 2022 empowered RedHill Biopharma with the data needed to initiate discussions with regulators.

‍

Testimonial

When glitches arose, as would be expected in a novel situation such as this, the ObvioHealth team was available to work through the problems and correct them for subsequent patient entry. I’d feel very comfortable recommending ObvioHealth.

Dr. Terry Plasse
Medical Director at RedHill Biopharma

‍

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Case Study

COVID-19 Case Study: Monitoring Patients Remotely Using Digital Devices

ObvioHealth successfully conducted a clinical trial for RedHill Biopharma to test the safety and efficacy of an oral medication for the treatment of COVID-19 symptoms. We designed this decentralized study to be conducted where the majority of patients recover from illness—in their homes. When the trial was launched in 2021, its unique combination of home health visits, electronic patient-reported outcomes (ePRO), and remote monitoring devices was pioneering—COVID-19 studies were typically conducted inside hospitals.

Infectious Disease
Download the PDF

Challenge

Because the patients in this study were experiencing symptoms associated with COVID-19, RedHill Biopharma sought to reduce participant burden as much as possible. The sponsor recognized that site and clinic visits would not only be a nuisance for ill patients but would also expose healthcare staff to the risk of contracting the virus. However, the seriousness of the virus—in addition to its largely enigmatic status at the time—necessitated a high degree of clinical oversight.

RedHill’s study required:

1. The ability to recruit patients in the geographic areas where COVID-19 was spiking.

2. The monitoring of patients’ vitals for both efficacy and safety tracking.

3. Assessments by clinicians.

‍

Solution

ObvioHealth designed a remote study using a combination of home health visits, digital monitoring devices, and ePRO.

Recruitment

The study was conducted in both the U.S. and South Africa. To accelerate recruitment, ObvioHealth employed digital strategies—built into the decentralized design of the study—to identify COVID-19 hot spots and recruit swiftly in those designated areas. Enrollment occurred on-site, where the patients consented and were trained on proper device usage.

Digital Monitoring Devices

Patients used three remote monitoring devices at home to capture vitals and other measures, including temperature, oxygen saturation, and ECG. The data points from these devices were transferred directly into ObvioHealth’s system, where they were closely monitored for any irregularities.

Health Visits

Patients were given the option of either home health visits or on-site visits. These visits included blood sample collection and PCR swabs.

ePRO

Using ObvioHealth’s app, patients recorded their symptoms daily for the first four weeks and then three times per week for the remaining four weeks.

‍

Results

RedHill Biopharma followed patients daily for two months, collecting vital signs that were imperative to the study’s endpoints. Data collection of this magnitude would not have been possible within the strictures of a traditional, in-person trial.  
‍
The successful study endpoints achieved in early 2022 empowered RedHill Biopharma with the data needed to initiate discussions with regulators.

‍

Testimonial

When glitches arose, as would be expected in a novel situation such as this, the ObvioHealth team was available to work through the problems and correct them for subsequent patient entry. I’d feel very comfortable recommending ObvioHealth.

Dr. Terry Plasse
Medical Director at RedHill Biopharma

‍

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