CLINICAL TRIALS PROFILE FOR CHLOROQUINE PHOSPHATE

All Clinical Trials for CHLOROQUINE PHOSPHATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00140517 ↗	Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance	Completed	DBL -Institute for Health Research and Development	N/A	2002-10-01	Plasmodium falciparum resistance to chloroquine (CQ) and sulfadoxine-pyrimethamine (SP) continue to spread, impeding control of this important disease. CQ and SP are still the most commonly used antimalarial drugs for malaria prevention during pregnancy and might be made less effective by resistance. However, the treatment and prophylaxis regimens used may also create conditions for selecting resistant malaria parasite strains. A better understanding of the relationships between chemoprophylaxis regimens and resistance would be helpful to improve chemoprophylaxis of malaria in pregnancy. This work aims to improve the use of chemoprophylaxis in pregnancy by determining whether there is a relationship between the use of standard prophylactic regimens with CQ and SP and the occurrence of P. falciparum resistant strains in pregnant women. The study consists of 2 parts. The first part is a randomized trial comparing 3 chemoprophylactic treatment groups: - weekly CQ after initial presumptive CQ treatment, - CQ intermittent presumptive treatment given as a standard dose at 2nd and 3rd trimester, respectively and SP intermittent presumptive treatment given as a single dose at 2nd and 3rd trimester, respectively. These treatment groups will also be compared to a group of women delivering at the same health centre but who have not been participating in the study. The second part will be a clinical trial for assessment of clinical and parasitological efficacy of CQ and SP treatment in pregnant women presenting with uncomplicated malaria attacks. The study will be conducted from October 2002 to March 2005 in a health centre of Ouagadougou, Burkina Faso where malaria transmission is seasonal and resistance to CQ and SP is low.
NCT00140517 ↗	Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance	Completed	Gates Malaria Partnership	N/A	2002-10-01	Plasmodium falciparum resistance to chloroquine (CQ) and sulfadoxine-pyrimethamine (SP) continue to spread, impeding control of this important disease. CQ and SP are still the most commonly used antimalarial drugs for malaria prevention during pregnancy and might be made less effective by resistance. However, the treatment and prophylaxis regimens used may also create conditions for selecting resistant malaria parasite strains. A better understanding of the relationships between chemoprophylaxis regimens and resistance would be helpful to improve chemoprophylaxis of malaria in pregnancy. This work aims to improve the use of chemoprophylaxis in pregnancy by determining whether there is a relationship between the use of standard prophylactic regimens with CQ and SP and the occurrence of P. falciparum resistant strains in pregnant women. The study consists of 2 parts. The first part is a randomized trial comparing 3 chemoprophylactic treatment groups: - weekly CQ after initial presumptive CQ treatment, - CQ intermittent presumptive treatment given as a standard dose at 2nd and 3rd trimester, respectively and SP intermittent presumptive treatment given as a single dose at 2nd and 3rd trimester, respectively. These treatment groups will also be compared to a group of women delivering at the same health centre but who have not been participating in the study. The second part will be a clinical trial for assessment of clinical and parasitological efficacy of CQ and SP treatment in pregnant women presenting with uncomplicated malaria attacks. The study will be conducted from October 2002 to March 2005 in a health centre of Ouagadougou, Burkina Faso where malaria transmission is seasonal and resistance to CQ and SP is low.
NCT00140517 ↗	Relationships Between the Use of Antimalarial Drugs in Pregnancy and Plasmodium Falciparum Resistance	Completed	London School of Hygiene and Tropical Medicine	N/A	2002-10-01	Plasmodium falciparum resistance to chloroquine (CQ) and sulfadoxine-pyrimethamine (SP) continue to spread, impeding control of this important disease. CQ and SP are still the most commonly used antimalarial drugs for malaria prevention during pregnancy and might be made less effective by resistance. However, the treatment and prophylaxis regimens used may also create conditions for selecting resistant malaria parasite strains. A better understanding of the relationships between chemoprophylaxis regimens and resistance would be helpful to improve chemoprophylaxis of malaria in pregnancy. This work aims to improve the use of chemoprophylaxis in pregnancy by determining whether there is a relationship between the use of standard prophylactic regimens with CQ and SP and the occurrence of P. falciparum resistant strains in pregnant women. The study consists of 2 parts. The first part is a randomized trial comparing 3 chemoprophylactic treatment groups: - weekly CQ after initial presumptive CQ treatment, - CQ intermittent presumptive treatment given as a standard dose at 2nd and 3rd trimester, respectively and SP intermittent presumptive treatment given as a single dose at 2nd and 3rd trimester, respectively. These treatment groups will also be compared to a group of women delivering at the same health centre but who have not been participating in the study. The second part will be a clinical trial for assessment of clinical and parasitological efficacy of CQ and SP treatment in pregnant women presenting with uncomplicated malaria attacks. The study will be conducted from October 2002 to March 2005 in a health centre of Ouagadougou, Burkina Faso where malaria transmission is seasonal and resistance to CQ and SP is low.

Clinical Trial Conditions for CHLOROQUINE PHOSPHATE

Condition Name

Condition Name for CHLOROQUINE PHOSPHATE
Intervention	Trials
COVID-19	12
Malaria	10
Vivax Malaria	4

Condition MeSH

Condition MeSH for CHLOROQUINE PHOSPHATE
Intervention	Trials
Malaria	18
COVID-19	16
Malaria, Vivax	10

Clinical Trial Locations for CHLOROQUINE PHOSPHATE

Trials by Country

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−

Trials by Country for CHLOROQUINE PHOSPHATE
Location	Trials
Indonesia	11
United States	9
Thailand	8
Ethiopia	5
Brazil	5

Trials by US State

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−

Trials by US State for CHLOROQUINE PHOSPHATE
Location	Trials
New York	2
Arizona	1
Connecticut	1
Virginia	1
Maryland	1

Clinical Trial Progress for CHLOROQUINE PHOSPHATE

Clinical Trial Phase

Clinical Trial Phase for CHLOROQUINE PHOSPHATE
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	11
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for CHLOROQUINE PHOSPHATE
Clinical Trial Phase	Trials
Completed	27
Not yet recruiting	7
Terminated	4

Clinical Trial Sponsors for CHLOROQUINE PHOSPHATE

Sponsor Name

Sponsor Name for CHLOROQUINE PHOSPHATE
Sponsor	Trials
University of Oxford	7
Medicines for Malaria Venture	4
Shahid Beheshti University of Medical Sciences	4

Sponsor Type

Sponsor Type for CHLOROQUINE PHOSPHATE
Sponsor	Trials
Other	121
Industry	9
U.S. Fed	3

Chloroquine Phosphate: Clinical Trials, Market Analysis, and Projections

Introduction

Chloroquine phosphate, a drug historically used for the treatment of malaria and amebiasis, gained significant attention during the COVID-19 pandemic for its potential in treating COVID-19 associated pneumonia. Here, we will delve into the updates on clinical trials, market analysis, and future projections for this drug.

Historical Context and Initial Findings

Chloroquine phosphate has been in use for decades, primarily for malaria and amebiasis. However, with the onset of the COVID-19 pandemic, researchers began exploring its antiviral properties against SARS-CoV-2. Initial reports from China in early 2020 suggested that chloroquine phosphate showed apparent efficacy in treating COVID-19 associated pneumonia, with significant improvements in pneumonia and lung imaging, and reductions in the duration of illness[1][3][4].

Clinical Trials Update

Several clinical trials were initiated to assess the effectiveness of chloroquine phosphate and its derivative, hydroxychloroquine, in treating COVID-19.

Early Clinical Trials

The first clinical results were reported in a news briefing by the Chinese government in February 2020, indicating that treatment with chloroquine phosphate resulted in significant improvements for over 100 patients. These findings, although promising, were based on combined data from several ongoing trials with various study designs and lacked randomization, introducing potential biases[1][3].

Ongoing and Registered Trials

To address the limitations of early trials, more than twenty clinical trials were registered to evaluate the use of chloroquine and hydroxychloroquine. These trials employ different study designs, including open-label randomized, open-label non-randomized, and single-blinded randomized trials. They also vary in exclusion criteria and treatment approaches, such as using chloroquine or hydroxychloroquine alone or in combination with other drugs[1].

Recent Trial Findings

A small randomized controlled trial (RCT) compared chloroquine with lopinavir/ritonavir in hospitalized COVID-19 patients. The results suggested that chloroquine might be more effective in clearing the virus and improving lung clearance, although the study was small and had poor methodology, leading to a high risk of bias[3].

Biological Mechanism

Chloroquine and hydroxychloroquine have shown antiviral activity against SARS-CoV-2 in vitro studies. Hydroxychloroquine was found to be more potent than chloroquine, with an EC50 of 0.72 μM compared to 5.47 μM for chloroquine. These drugs also have immunomodulatory effects, particularly in controlling the cytokine storm in critically ill patients[3].

Safety and Contraindications

While chloroquine and hydroxychloroquine have shown promise, their use must be carefully considered due to potential side effects. Hydroxychloroquine is generally considered to have a better safety profile compared to chloroquine. Contraindications for each individual must be checked before treatment, and further research is needed to understand the optimal dose, duration of treatment, and long-term outcomes[1][3].

Market Analysis

Current Market Size

The global chloroquine phosphate market experienced a significant surge during the COVID-19 pandemic. As of 2023, the market size was estimated to be around US$ 131.6 million[2].

Market Forecast

Despite the initial surge, the market for chloroquine phosphate is expected to decline in the coming years. By 2032, the market is projected to reach US$ 44.5 million, reflecting a decrease as the pandemic subsides and other treatments become more prevalent[2].

Regional and Application-Based Analysis

The market analysis also includes regional and application-based forecasts. The demand for chloroquine phosphate varies by region, with significant demand during the pandemic period primarily driven by countries heavily affected by COVID-19. The application-based analysis indicates that the drug's use is expected to remain primarily in the treatment of COVID-19 associated pneumonia, although its traditional use in malaria and amebiasis will continue[5].

Market Dynamics and Drivers

The market dynamics for chloroquine phosphate are influenced by several factors, including the ongoing pandemic, government regulations, and the development of alternative treatments. The initial surge in demand was driven by the urgent need for effective treatments against COVID-19. However, as vaccines and other treatments became available, the demand for chloroquine phosphate began to decline[5].

Future Projections

Declining Demand

The future projections indicate a declining demand for chloroquine phosphate as the COVID-19 pandemic subsides and other treatments become more widely available. The market is expected to stabilize at a lower level, primarily driven by its traditional uses in treating malaria and amebiasis[2].

Research and Development

Despite the declining market, research on chloroquine phosphate and hydroxychloroquine will continue to address the gaps in current evidence. Further clinical trials are necessary to determine the optimal dosing regimens, side effects, and long-term outcomes. This ongoing research could potentially lead to new applications or improved treatment protocols[1][3].

Key Takeaways

• Clinical Trials: Initial trials showed promise, but further research is needed to confirm efficacy and safety.
• Market Size: The global market peaked during the pandemic but is expected to decline.
• Safety and Contraindications: Hydroxychloroquine has a better safety profile, but careful consideration is necessary.
• Future Projections: Demand will decline as the pandemic subsides, but research will continue.

FAQs

Q: What is the current status of chloroquine phosphate in treating COVID-19?

A: Chloroquine phosphate has shown apparent efficacy in early clinical trials, but further research is needed to confirm its effectiveness and safety.

Q: How does hydroxychloroquine compare to chloroquine?

A: Hydroxychloroquine has a better safety profile and is more potent than chloroquine in vitro studies.

Q: What are the potential side effects of chloroquine phosphate?

A: The drug can have significant side effects, and contraindications must be checked for each individual before treatment.

Q: What is the projected market size for chloroquine phosphate by 2032?

A: The market is expected to decline to around US$ 44.5 million by 2032.

Q: Will chloroquine phosphate continue to be used after the COVID-19 pandemic?

A: Yes, it will continue to be used for its traditional applications in treating malaria and amebiasis.

Sources

1. CEBM: "Chloroquine and Hydroxychloroquine: Current Evidence for Their Effectiveness in Treating COVID-19"
2. IMARC Group: "Chloroquine Phosphate Prices, News, Analysis and Forecast"
3. PAHO: "COVID-19: Chloroquine and Hydroxychloroquine Research"
4. BST: "Chloroquine Phosphate Has Shown Apparent Efficacy in Treatment of COVID-19 Associated Pneumonia"
5. Southeast News Channel Nebraska: "Chloroquine Phosphate Market 2024 Growth Analysis by Market Estimation, Manufacturers, Product Types, Gross Margin, and Forecast to 2030"